Hip Implant Recall
The End to End Process

Introduction

A hip implant recall is just one event in what is quite a lengthy end to end product life cycle process.

The process begins with hip joint manufacturers designing, developing and testing medical devices for introduction 'live' to the health care arena.

Thankfully, in practice, the vast majority of hip implant products prove to be safe and robust, fully satisfying the minimum safety and performance standards that are prescribed in whichever country they are used.

However, each year, a relatively small percentage of hip devices or components are the subject of a hip implant recall because:

  • Either the device fails to perform as expected, and there is emerging evidence that suggests that the device may be causing actual health problems for some recipients
  • Or investigation and analysis carried out on a replacement hip device after its introduction to the market identifies incremental risks that were not identified prior to the product being approved for use. The manufacturer (or the regulatory agency) recalls the device in an attempt to avoid the possibility of people being harmed by the product.

About this page

By way of orientation, this Tier 2 page provides a backbone to much of the content on this website.

If you quickly page down to the bottom you'll notice that this is a MONSTER page in terms of its length! I have provided some extra links here & there to help you navigate quickly up, down & around.

The objective of the page is to provide a simple, high level and (hopefully!) understandable walkthrough of the end to end hip implant recall process. Remember - this is just my (layman's) assessment & summary of the process at a high level - my best attempt to simplify and try to bring some structure to bear.

I may have missed some elements (hopefully nothing major!). I may have failed to adequately describe the reality, nuances or dynamics of some of the process steps. I would welcome any feedback based on your own experiences. Please pay it forward using the Contact form, and help me make this page as useful as possible for all Visitors. Thanks!

Think of the process flow as a river. We start at source at the top of the page, and work down chronologically until the river meets the ocean.

The main body of information is set out below in three tables (Process A, Process B and Process C) with links interspersed to supporting information elsewhere on this site (Tier 3 pages).

The timelines in the tables are not 'to scale' i.e. they are 'non-linear', for example:

  • The initial phase of product design, development & testing by manufacturers can take many years;
  • In contrast, from the date of introduction of a product to the market, to the point where problems present and a product is recalled, could take only six months.

My purpose in presenting information in this way is to try to simplify what potentially is quite a complex process.

There are many different people, companies and organizations involved at different stages of a hip implant recall, all doing different things with different objectives. However, certain things do happen in a broadly predictable, chronological order. For example, in theory:

  • A hip implant device needs to be fully tested before the device is submitted for regulatory approval;
  • Regulatory approval should be granted before a device is introduced for use in the market.
  • Typically there is evidence of actual injury or concern about the possibility of injury, prior to a hip implant recall being initiated.

In contrast, towards the back end of the process, things can get a bit fluid and activities can happen in a different order depending on circumstances and decisions made. For example:

  • A patient may need and choose to have revision surgery to replace a hip implant that is thought to be causing health problems prior to the implant being recalled;
  • Or, a hip implant device may be recalled; which prompts a patient to contact his doctor who recommends medical tests. Depending on the results of the tests, the doctor will work with the patient to agree a way forward; this could be for example a short term strategy of 'do nothing' and 'wait and see'; possibly followed later by revision surgery.

My overriding objective is to simplify and provide some structure to illustrate:

  • Who is involved in the hip implant recall process
  • What they're each doing and why
  • The rough chronological order in which things tend to happen (subject to the notes above)

One thing to bear in mind: towards the end of the process, the 'River' actually forks and there are potentially two streams of activity flowing in parallel:

  • One stream deals with the highest priority activity, which is you and your health care professionals working together to best manage your health and well being. This is summarised as Process B below.
  • The other stream deals with the possibility that you may wish to investigate taking legal action as a consequence of the hip implant recall. This is summarised as Process C below.

Hip Implant Recall Process

Process A

Note: The hip implant recall (key decision point) takes place at process stage A11 below.

Process Stage

Commentary & Notes

A1

Product design and development

The process starts with medical product manufacturers designing and developing hip implant products.

It should be stated that in all cases the objective of the manufacturers is to develop products that are safe and reliable, and that will improve the quality of life of the recipient once fitted.

No manufacturer sets out with the intention to cause harm or injury, but regrettably, a small proportion of medical products are released into the market which subsequently need to be recalled.

A2

Product testing

Manufacturers invest heavily in product testing to minimize the risk that harmful products could be introduced to the market.

Companies face a dilemma in that they strive to develop products that are technically innovative, for example, using new designs or materials, but at the same time they must balance and mitigate against the risk of harming patients.

The orthopaedic implant industry and the large corporate entities that dominate it are worth billions of dollars. The sales, profits and stock market valuations of these companies are directly linked to the strength of the brand name of each, and the reputation for quality, safety and reliability of their medical products.

A hip implant recall can cause significant damage to a brand. For this reason all manufacturers invest very heavily in meticulous product design, development and testing in order to minimize the risk that a product (of any type) will need to be recalled.

A3

Application for regulatory approval

Prior to release into the market, hip implant products require regulatory approval from the appropriate authority in the intended country of use.

The approving / regulatory bodies set and manage the minimum safety standards which medical products must meet.

The same organisations will typically be consulted and closely involved in any hip implant recall decision (stages A9 onwards).

A4

Product approval granted

Standards and approval processes vary by country, but in simple terms a regulatory body will grant approval for a product only when the manufacturer has demonstrated that the hip implant has met the minimum prescribed safety standards.

Product approval does not necessarily indicate that a product is risk-free. Any residual risks that are inherent to the product must be clearly stated in any marketing or promotional material used to describe the product or its benefits.

A5

Surgeons and other Healthcare professionals trained in the use of the device

Hip implant manufacturers work very closely with a range of health care professionals, including orthopedic surgeons as new products are developed.

As each new hip implant system is released to the market the health care professionals who will be using it in the field receive education and training to ensure that they understand the characteristics, benefits and risks of the product.

The active involvement of health professionals at all stages of the product life cycle is of critical importance. Very often it will be the front-line health practitioners who will notice early warning signs - that might ultimately lead on to a full hip implant recall.

A6

Distribution intermediaries appointed

Hip implant manufacturers are typically global businesses that rely on intermediary companies to import and distribute products within nominated countries / territories.

The importer or distributor will often be granted a license to be the sole distributor in a particular country or region.

A7

Product introduced to the market

Doctors, consultants and surgeons start to recommend and fit the recently approved hip replacement devices - 'live' with real patients.

A8

Post-market surveillance of patients

Once a new hip replacement system is in use 'live', a range of information and data is collected to enable the effectiveness of the product to be assessed.

The approach, mechanisms and responsibility for collecting and compiling information vary from country to country.

In broad terms each country has its own independent National Joint Registry, with orthopedic surgeons, clinics and hospitals collecting raw data and passing it through to the central registry for consolidation and interpretation.

KW: [ ]

A9

Problems begin to present

Patients experience problems with the performance of their replacement hip joint and /or other health problems that may be caused by the hip implant.

Doctors, surgeons and hospitals capture this information and pass it to the joint registries, the regulatory authorities and the product manufacturers.

A10

Investigation and analysis of problems

Manufacturers and regulatory agencies carry out investigation and analysis to:

  • identify the root cause(s) of the problems experienced;
  • assess the nature, scale, and severity of the issues;
  • decide whether the product should be withdrawn from use

A11

Hip implant device is recalled

Key decision point: Hip implant recall

The decision is made either by the manufacturer or the regulatory agency that the hip implant should be recalled.

A12

Notifications to interested and impacted parties

The manufacturer and the regulatory agency communicate the product recall to distributors, surgeons, doctors and other interested parties.

Patients who have received these implants should be contacted, however processes and controls to ensure that this notification actually happens vary from country to country.

A13

Press and media frenzy

News of the hip implant recall spreads rapidly, and stories start to appear in the public domain including news media and the Internet.

A14

Medical assessment and tests

Patients affected by the hip implant recall start to work with their orthopaedic surgeons, doctors and other healthcare professionals to assess their hip joint and any potential wider adverse health issues that may be related to the recalled hip implant.

Doctors may recommend that specific tests / procedures are carried out which may include: X-rays; blood tests; ultrasound / MRI.

For further details refer to process B below.

A15

Lawyers and Attorneys are engaged to act for injured patients.

Impacted patients start to make contact with lawyers and attorneys to help them understand their legal rights and whether they might have a legitimate and potentially winnable case for compensation.

Process splits:

Medical process: See Process B below

Legal process: See Process C below


Medical Process

Process B

Process B below describes activities, some or all of which are typically undertaken after a hip implant recall has taken place.

However, it is important to stress that regardless of whether the device that you have fitted has been subject to a hip implant recall, should you have any concerns about the performance of your hip implant or be having any health problems then you should consult your doctor or orthopaedic surgeon without delay.

Process Stage

Commentary & Notes

B1

Initial examination and assessment.

If patients develop symptoms that suggest that a device that is the subject of a hip implant recall may not be functioning correctly, it is vital that an evaluation is carried out by their orthopaedic surgeon.

The orthopedic surgeon will most likely:

  • review the full history of the patient and the hip replacement procedure;
  • carry out a physical examination
  • possibly recommend further tests (see B2 immediately below)

Depending on circumstances, in particular whether the patient still has confidence in the surgeon that performed the initial hip replacement procedure (primary surgery), the patient may prefer to work with a different orthopeadic surgeon for this post-operative examination & assessment and for all future management of the hip joint.

B2

Tests

Doctors may recommend that specific tests / procedures are carried out which may include:

  • X-rays
  • ultrasound / MRI
  • blood tests

In simple terms the objectives of these tests are to:

  • Assess the extent to which the artificial hip joint is functioning properly
  • Assess whether, and if so the extent to which the metal on metal components in the hip joint have worn, and therefore the potential scale of release of metal particles into the body
  • Assess whether the hip implant has caused or is likely to cause damage to either soft tissue or bone in the hip area
  • Assess the levels of cobalt and / or chromium in the blood

B3

Wider health assessment

The examinations, tests and assessments summarized above (B1 & B2) are specific to the hip joint and surrounding areas, and possible issues that might be related to a prosthesis that is subject to a hip implant recall.

Doctors will also assess and take full account of the wider health circumstances and lifestyle of the patient before moving on to discuss with the patient possible courses of action or inaction (see B4 below).

B4

Consideration of courses of action (or inaction)

Based on the unique circumstances of each case, doctors will explain to the patient the various options for managing the hip joint going forward.

Sometimes, following a hip implant recall, the best course of action will appear to be relatively clear, based on the doctor's assessment of the benefits and risks.

Sometimes a very finely balanced judgment will be required through which the patient and the doctor will evaluate and weigh the relative benefits and risks of:

  • Either: the 'monitor closely / wait & see' approach
  • OR revision surgery in the short term
  • OR another option, depending on the specific circumstances of the patient

B5

Possible revision surgery

If the decision reached by the patient following detailed consultation with his doctor or orthopaedic surgeon is that revision surgery is the preferred course of action, then this can be scheduled and carried out.

It is important to note once again that just because an implant has been subject to a hip implant recall (or is a metal on metal device and not yet recalled), it does not necessarily follow that revision surgery will be required.

Furthermore, just because a medical device has been recalled (or is of metal on metal design / construction), it does not necessarily mean that it is faulty / defective, or that it has caused (or may in future cause) harm to patients.

Only the doctor or orthopedic surgeon, working closely with the patient, can make these judgments on a case by case basis weighing all benefits, risks and circumstances that are unique to each patient.

B6

Ongoing health care and monitoring

Regardless of the decision made with respect to whether revision surgery is required, the orthopaedic surgeon, the primary (family) doctor and the patient will agree a plan to monitor the hip joint and the wider health of the patient on an ongoing basis.

The frequency of monitoring and possible future tests will be as advised by regulatory agencies and health care professionals, depending on the specific nature of the hip implant recall.

See also: For a general discussion on the relationship between hip replacement complications and a hip implant recall click here.


Legal Process

Process C

See also: Hip Replacement Lawsuit - the Basics

Important!!

It is important to stress that regardless of any other circumstances or the status / timing of a hip implant recall, if you think you may need to initiate a legal action, then you should not delay having at least a preliminary discussion with a lawyer - personal injury lawsuits are often subject to the statute of limitations.

If this is the case then there will be a prescribed date, beyond which you will not be able to initiate a legal action. Your lawyer will be able to advise whether the statute of limitations applies to your case / situation, and if so, the key dates that you need to be aware of.

Early stages

During the very early stages of the legal process, a lawyer will seek confirmation from his client that that a few basic preparatory actions / steps have been completed:

  • That the recipient (of the hip implant)
    • has positive confirmation that the implant he has fitted is the subject of a hip implant recall OR
    • there is emerging evidence that patients with implants of that particular type are experiencing unexpected health problems that may be related to the implant
  • That the recipient has had at least an initial discussion with his orthopaedic surgeon, and a preliminary medical examination and assessment (B1 above) of the functioning of his hip implant. The tests summarised at process stage B2 (above) may or may not have been carried out at this point.

Process Stage

Commentary & Notes

C1

Awareness of possibility to take legal action arising from a hip implant recall.

High level consideration of the nature of a potential legal action.

Product liability

At this very early stage the patient will have established that he has been fitted with a hip implant that has been recalled. He is aware that he may have suffered some personal injury as a consequence of the medical product being defective. This situation falls into the broad category of Product Liability

The personal injury may be current i.e. his hip implant may already be failing with symptoms such as pain, dislocation or component loosening being evident.

Alternatively, potential personal injury may be possible in the future as a consequence of the recalled hip implant - this might include:

  • the possible need to undergo revision surgery to replace the device - this additional surgery would not be required were it not for the hip device possibly being defective;
  • possible adverse health issues caused by metallosis in the case of a recalled metal on metal implant

Medical malpractice

In addition to the above scenarios (C1), it is possible that the root cause of a hip replacement related personal injury is medical malpractice. This could be the case whether or not the hip device is subject to a hip implant recall.

For example the device may:

  • have been incorrectly fitted;
  • be the wrong size;
  • be of a design or construction that is inherently unsuitable for the recipient.

These are examples of actions / decisions typically made by the orthopaedic surgeon who carried out the primary (initial) hip replacement procedure.

C2

Discussion with family and friends.

Research.

'In principle' decision to explore legal action.

The recipient of the implant will think through whether he feels that he has suffered a personal injury, whether this is related to a hip implant recall, and whether he has an appetite to explore the possibility of taking legal action.

People typically do not embark on legal action lightly. The process can be stressful, lengthy, and is not necessarily without some personal financial risk, despite headline advertisements from many lawyers stating 'No win, No fee'.

In the situation where there has been a hip implant recall, individuals will react in different ways and have varying priorities:

  • Some may decide that they have no appetite to work through a potentially onerous, lengthy and stressful legal battle
  • For others there may be no viable alternative if the only way to potentially fund treatment and get compensation for loss of earnings / life quality is a legal action

Often further research is undertaken using the internet, forums, help groups etc.

Following a period of reflection and discussion with family and friends, the injured party will make his or her decision as to whether to explore the possibility of taking a legal action.

C3

Identify candidate Lawyers

Assuming the decision is to progress with a potential legal action, the next step is to find a lawyer to work with.

As an aside, for visitors from the US, it is important that you are clear on the difference between a Lawyer and an Attorney; click here from more information.

C4

Injured party selects his / her Attorney

  • Interview
  • Short list
  • Selection

The choice of appropriate legal representation is an absolutely critical decision.

The capability and experience of the legal firm chosen can fundamentally influence:

  • the assessment of what type of case the individual should pursue
  • the assessment of the strength or weakness (winability) of a particular case, given all of the key facts
  • the final outcome of the case
  • The extent to which the Plaintiff (You) faces financial risk should you loose the case

Unfortunately, this crucial step can sometimes be made more difficult by the proliferation of attorney advertising through various media including radio, TV and Internet. The legal profession in most countries is regulated to control the content of advertisements for legal services; the broad objective of the regulation is to protect the public from being misled as to the capabilities, skills and track record of one firm relative to another.

Often people take recommendations from family or friends who have had either good or bad experiences with particular legal firms - arguably, this approach is a little hit and miss.

I have compiled a schedule of the criteria and related rationale that I would apply when selecting candidate legal firms to represent me in a hip implant recall case. I hope it gives you some ideas and helps you with your own selection process. Good luck!

Also, based on my own research, I have created a list of questions that I (personally) would ask a lawyer in an initial meeting, and before appointing the firm to represent me. Link to FAQs: What Qs should I ask a lawyer I'm considering hiring? LINK KW: [ ]

My lists are no doubt incomplete, and not all questions will apply in all cases or all jurisdictions, nevertheless I hope they provide a starting point for your own search & deliberations.

Ok, so, moving on through the process: the injured party makes contact with a selection of legal firms; ideally meets with a representative from each of a small number of firms to interview them; makes a short list and ultimately selects a firm to represent them.

Prior to making my decision on which lawyer to appoint, I would want to have a copy of the draft letter of engagement and draft client / attorney contract from each of the legal firms I shortlist.

The draft contract (sometimes referred to as the 'contingency fee retainer agreement') will ultimately become the legal contract between me as the Plaintiff and my legal representative. In my view it is essential that anyone making the decision about which firm to select is given a draft copy of what will become the contract between the client and that lawyer, if appointed.

Before I would commit to one particular legal firm, I would want to compare these contracts side by side to understand the key differences (if any) between them.

C5

Decision point:

  • Legal action?
  • No legal action?

Once the injured party has met and discussed his case with the short-listed legal firms it is time to make a decision.

Again, this is a critical decision point for the individual (Plaintiff).

Once an individual chooses a firm and signs the contract which appoints that firm to represent him, the firm will start to work and incur fees & expenses on his behalf. If he decides later that he no longer wishes to progress the case, he may be liable for the legal fees & expenses incurred by his lawyer.

OR, if ultimately his case is not successful, there is a risk (depending on the country / jurisdiction) that he may be liable for the expenses incurred by his lawyer plus the legal fees & expenses of the Defendant. This financial exposure could be substantial.

For these reasons it is important that anyone appointing a lawyer and thereby initiating a legal action has:

  • a full and clear understanding of the contract that he or she is entering into with their lawyer;
  • received objective advice on the strength of their legal case;
  • understood the financial implications for all parties (You as the Plaintiff; your lawyer; the Defendant) in the event that the Plaintiff:
    • Wins his case (how will any award be distributed?)
    • Abandons his case partway through
    • Loses his case

In summary, an individual should make an informed decision, based on objective and unbiased information from lawyers contacted, and the wise counsel of family and friends, as to whether to initiate a legal action, and if so, which legal firm to select to represent him.

C6

Formal engagement of attorney

The injured party in a hip implant recall case (you) enters into a legally binding contract with an attorney. This is a key staging point in the legal process - at this point a formal client / attorney relationship is established.

The contract signed will be the key reference document that both the client and the attorney will refer to throughout the lifecycle of the legal action.

The contract terms are of critical importance as they will define both the upside and the downside risks for both the attorney and the client. As you might expect, some hip implant recall cases will be relatively straightforward; others less so.

In simple terms, this contract defines for both the client and the attorney:

  • Who will ultimately pay the fees and expenses that are incurred as an integral part of the legal action. Note: the contract terms covering responsibility for payment of fees and expenses is critical, as in certain circumstances the client might be liable to pay
  • How any compensation or award will be split between the attorney and the client should the legal action be successful
  • The respective roles, rights and responsibilities of both parties
  • How the attorney will manage the case end to end, depending on the various possible ways that the case could develop or play out

C7

Preparation of the potential case

The attorney (or his in-house support team) will undertake a detailed process to prepare the legal case. In summary, This process will include:

  • Sourcing and reviewing documents, files and information to create a fact base which will form the foundation of your case
  • Interviewing you and possibly other third parties to gather supporting information
  • Other investigation, research, analysis & ground work to understand all key aspects of the hip implant recall

The primary objective of these activities is to gather together all relevant information to enable the attorney to form his own professional opinion as to whether you actually have a case, and if so, the strength (potential winability) of your case, and the potential financial value of the case.

C8

Decision point:

  • Strong case?
  • Weak case?
  • No case?

The next key decision point will be the client and the attorney meeting to discuss and agree whether a formal legal action will be launched.

The discussion will include the following:

  • Finalization of the type of case: medical product liability; medical malpractice; other
  • Identify defendant(s) - the individuals or companies that will be sued
  • Decide the strength of case and discuss the balance between risk and reward depending on the various possible outcomes

The client and attorney decide whether a formal legal action will be launched. If the decision is to progress and initiate a formal legal action, then the legal process continues at C9 below.

Alternatively, if the decision is to take the case no further, both parties will refer to the client attorney contract to determine how the attorney's file will be closed down and whether the client is liable to pay any of the attorney's fees or other expenses incurred to that point in time.

C9

Preparation of full case

The attorney and his support team will complete their detailed preparation for the legal action.

C10

Prosecution of the case

The attorney will initiate the legal action and manage the prosecution of the case from end to end.

Each case is unique. Ultimately every hip implant recall case will be either: successful; abandoned partway through; or unsuccessful.

The particular course or pathway that the case will follow can be difficult to predict and may vary depending on factors such as:

  • the type of case;
  • the facts of the case;
  • the tactics & strategies chosen by your lawyer and by the lawyer acting on behalf of the defendant(s);
  • a range of other variables.

C11

Settlement (out of court)

A significant proportion of hip implant recall lawsuits are settled out of court i.e.: before the case actually reaches court. This outcome is referred to as 'settlement'.

It is quite common for opposing legal teams to make several attempts at agreeing settlement.

The manufacturer of a (recalled) defective hip replacement joint will be well aware of the main advantages of settling a case out of court. Settlement is covered in more detail here, but in summary, an out of court settlement allows both parties to potentially save money, time and avoid the hassle & stress that is typically involved in taking a case to court.

However, some cases do not settle in this way and they actually progress to court, to be decided either by a judge or a jury.

C12

Case goes to court

If a hip implant recall case goes to court, the Plaintiff will usually be represented in court by his attorney.

Court proceedings follow processes that are determined by law, and can sometimes be complex and lengthy. A case can be decided either by a judge or by a jury depending on location and circumstances.

C13

Initial verdict

Once the case has been a presented and both the prosecution and defense have completed their work, the court will give its verdict.

C14

Possible appeal

If the defendant loses the case then it is quite possible that the company or individual will raise or lodge an appeal against the verdict. There are many potential reasons that an appeal might be raised.

C15

Final verdict

At some point, the court will deliver a final verdict, beyond which no further appeal is allowed.

If the prosecution case is ultimately successful, then the court will determine whether damages or compensation are payable, and if so the amounts involved.

If the case is unsuccessful then the Plaintiff may be required to pay the legal fees and expenses of the defendant. This will vary depending on the country in which the case is prosecuted.

C16

Distribution of funds

or Recovery of costs

The final stage of the hip implant recall legal process is for all parties to settle the various accounts that exist between them.

If the case has been successful, a carefully controlled process kicks in to recover funds from the defendant and distribute those funds between the client and the attorney. This allocation will be managed fully in line with the prescribed laws in the appropriate country or state. And the attorney / client contract that is described in stage C6

If the case has not been successful, a similarly well controlled process commences through which:

  • The defendant recovers from the Plaintiff the legal fees and other expenses that were incurred in defending the case
  • The attorney representing the Plaintiff may recover from the Plaintiff any fees or expenses incurred as set out in the attorney / client contract that is described in stage C6



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