What Is a Knee Replacement Recall?
A knee replacement recall is when a knee replacement device is either corrected or removed from the market. A correction addresses an issue that occurred with the knee replacement that occurred where it was either sold or used. A removal pulls the knee replacement or other device off the market in order to address an issue with it. Depending on the medical device that has been recalled, replacing it isn’t always the best solution, especially if it was surgically implanted, like a knee replacement. However, in the event of a recall, your doctor should contact you to inform you about both the recall and advise you about the risks of replacing the faulty device versus continuing to use the device in question.
Who Can Recall a Knee Replacement Device?
A recall can be initiated by the company that manufactures it if they discover a problem. This is called a voluntary recall. The FDA is also allowed by law to force a company to recall a medical device or other product if the company hasn’t already done so. The FDA has said that it rarely has to force a recall and typically companies initiate recalls themselves, but that the FDA has and will order recalls as needed to protect patients’ health and lives.
How Are Knee Replacement Devices Recalled?
Medical devices like knee replacement products can generally be recalled in three different ways. A manufacturer may voluntarily recall a product when evidence is showing that it may be harmful to patients. The U.S. Food and Drug Administration (FDA) may request that a manufacturer issue a recall based on adverse event reports and in more severe cases, or in cases where a manufacturer has not cooperated with a request, the FDA may issue a mandatory recall.
If a recall has not been issued as requested, the FDA may take further legal action and may seize defective products as needed. In most cases, manufacturers will issue a voluntary recall or comply with a jointly requested recall.
In the case of most knee replacement recalls that have been issued, products were voluntarily recalled or recalled in compliance with FDA concerns. Knee products have been recalled due to high numbers of adverse events or known problems that emerged in patients who had received the devices.
Why Are Knee Replacement Devices Recalled?
Knee replacements have to be recalled when a fault is found that can cause the device to fail. What this fault is depends on the knee replacement device and the company that manufactured it. Exactech’s knee replacements, for example, were impacted by the degradation of polyethylene liners and inserts, which was caused by exposure to air due to faulty packaging that wasn’t up to specifications.
What Are Common Causes of Knee Replacement Recalls?
Some common causes of knee replacement recalls can include:
- Device loosening
- Persistent and/or severe pain
- Damage to the bone, muscle, and nerves near the device
What Is Device Loosening?
Device loosening is when the joint replacement loosens and isn’t firmly attached to the bone. Loosening could also be if the components of the knee replacement aren’t firmly connected to each other. Correcting loosening typically requires revision surgery. The symptoms of loosening can include:
- A feeling that the joint is moving in an out of the socket
- A popping sound
- A clicking noise
- Full or partial dislocation of the knee
- Your knee feels like it’s giving out when you put weight on it
- Swelling around the knee joint
How Can a Knee Replacement Cause Infection?
It’s possible for an infection to occur without the knee replacement failing. Bacteria could grow on or around the components of the joint replacement, which could then cause an infection. However, an infection can also be a sign that the knee replacement has a problem. For example, an infection could be caused by debris from the knee replacement prosthesis if it had an issue that caused the components to break down.
Exactech’s knee replacements had this problem. Due to faulty packaging, the polyethylene liners and inserts for Exactech’s knee and ankle replacements were exposed to oxygen and therefore degraded more rapidly, causing many patients to have to undergo revision surgery to repair the issue.
How Can a Knee Replacement Cause Pain?
A knee replacement is supposed to alleviate joint pain. Typically, a knee replacement isn’t recommended by medical professionals unless they feel that there is no better option for relieving pain and loss of range of motion. People who get knee replacements typically are those who have difficulty walking without one and whose quality of life is impacted by their existing knees. Ideally, the replacement wouldn’t cause pain once the recovery from the surgery is complete. However, that’s not the experience that many people have with their knee replacements.
Pain can be a sign of a problem with the knee replacement or a sign that the device has failed or that there’s another problem with it. If you feel pain with your knee replacement, talk to your doctor.
How Can a Knee Replacement Cause Swelling?
Swelling is a symptom of multiple problems that can occur with a knee replacement. The knee replacement device could have loosened. Another possibility is an infection. If you notice that your knee is swelling at any time following a knee replacement surgery, you should mention it to your doctor, especially if it’s also painful. It can also be a sign that something is wrong with the knee replacement device.
How Can a Knee Replacement Damage Bones, Muscle, and Nerves?
A knee replacement literally replaces the existing knee joint with an artificial device. During the knee replacement surgery, the joint has to be removed and the knee replacement device attached with cement to the ends of the bone. If the knee replacement is faulty, then this can cause damage to the bones, muscle, and nerves that connect to it.
What Is Revision Surgery?
In many cases, patients who experience serious complications, severe side effects, or device failure must undergo knee replacement revision surgery. These surgeries are performed to fix or replace a faulty or broken device. In most cases, revision surgery will be more complex and require a longer recovery period than the original surgery. In addition, some patients may be required to undergo additional surgeries to reconstruct damaged joint tissue or repair bones that have fractured due to device failure.
In some cases, high revision rates for certain devices have prompted either the company to issue a recall or for the FDA to order the company to recall the device.
What Knee Replacement Devices Have Been Recalled?
The following knee replacement devices have been recalled:
|DePuy||Sigma HP PFJ Trochlear implants||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162430|
|DePuy||Sigma HP MBT Non-Keel Punch Knee Instruments||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143015|
|DePuy||Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120)||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139894|
|DePuy||Attune Conv FB CR Articulation Surface SZ1||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137734|
|DePuy||LCS Complete RPS Inserts||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136058|
|DePuy||Attune Intuition Impaction Handle||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132113|
|DePuy||Attune Intuition Impactors||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132113|
|DePuy||REF 623411 R S-ROM Noiles Rotating Hinge||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125865|
|Zimmer Biomet||Patello-Femoral Joint System Gender Solutions||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162411|
|Zimmer Biomet||Persona Partial Knee spacer block instruments||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162188|
|Zimmer Biomet||Persona Partial Knee System Spacer Block Alignment Tower||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165718|
|Zimmer Biomet||Various polyethylene implants||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154313|
|Zimmer Biomet||Vanguard Complete Knee System||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161468|
|Zimmer Biomet||Persona Trabecular Metal Tibial Plate Knee implants||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=133978|
|Zimmer Biomet||NexGen complete knee solution cruciate retaining||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=162406|
|Stryker||Orthopaedics Patella Assembly Instrument||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149119|
|Stryker||Modular Handle Triathlon Instruments||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148074|
|Stryker||MIS Modular Distal Capture Triathlon MIS Instruments||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140853|
|Stryker||Triathlon Femoral Distal Augment||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=176053|
|Stryker||Scorpio Total Knee Posteriorly Stabilized Femoral Component||https://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfres/res.cfm?id=69050|
|Stryker||ShapeMatch Cutting Guides||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115791|
|Smith & Nephew||Journey BCS Oxinium Knee Femoral Components||https://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfres/res.cfm?id=165170|
|Smith & Nephew||Journey BCS Oxinium Knee Femoral Components||https://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfres/res.cfm?id=165170|
|Smith & Nephew||Journey BCS Knee System||https://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfres/res.cfm?id=165170|
|Smith & Nephew||Legion TIB Cone Impactor Heads||https://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfRes/res.cfm?id=155986|
|Smith & Nephew||TC-Plus Primary Fixed Tibial Component VKS Left||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144571|
|Smith & Nephew||Legion Hemi Step Tibial Wedge||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=175821|
|Corin||Unity Knee Augments||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189055|
|Corin||Corin Unity Knee CS Insert||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189058|
|Corin||Corin Unity Knee Patella||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189060|
|Aesculap Implant Systems LLC||Univation X System knee implant devices||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=188391|
|Aesculap Implant Systems LLC||Univation X System Tray Sysem knee implant devices||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=188396|
|Arthrex||Arthrex iBalance TKA Tibial Tray Size 2||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143925|
|Arthrex||iBalance(R) UKA, Femoral Cemented||https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=159082|
|Exactech||OPTETRAK® TKR All-polyethylene Tibial Components||https://www.exac.com/medical-professionals/recall-information/|
|Exactech||OPTETRAK® PKR All-polyethylene Tibial Components||https://www.exac.com/medical-professionals/recall-information/|
|Exactech||OPTETRAK® TKR Tibial Inserts||https://www.exac.com/medical-professionals/recall-information/|
|Exactech||OPTETRAK® TKR HI-FLEX® Polyethylene Tibial Inserts||https://www.exac.com/medical-professionals/recall-information/|
|Exactech||OPTETRAK® TKR Custom Polyethylene Tibial Inserts||https://www.exac.com/medical-professionals/recall-information/|
|Exactech||OPTETRAK® LOGIC® TKR Polyethylene Tibial Inserts||https://www.exac.com/medical-professionals/recall-information/|
|Exactech||OPTETRAK® RBK® TKR Polyethylene Tibial Inserts||https://www.exac.com/medical-professionals/recall-information/|
|Exactech||OPTETRAK® Logic RBK TKR Tibial Components||https://www.exac.com/medical-professionals/recall-information/|
|Exactech||ARTHROFOCUS® TKR Polyethylene Tibial Inserts||https://www.exac.com/medical-professionals/recall-information/|
|Exactech||TRULIANT® TKR Tibial Inserts||https://www.exac.com/medical-professionals/recall-information/|
Why Were DePuy Knee Replacement Devices Recalled?
DePuy recalled a number of different knee replacement devices for several different reasons. In some cases, they found defects with the products that caused them to fracture and potentially leave pieces behind in a patient that shouldn’t be. In other cases, they discovered that there was a higher revision rate than usual and even though there wasn’t a specific reason identified for the recall, they pulled the knee replacement product off the market to discover why the revision rate was higher.
Why Were Zimmer Biomet Knee Replacement Devices Recalled?
Although Zimmer Biomet recalled knee replacement devices for a variety of reasons, the most common issue was that pieces of the knee replacement weren’t the correct size to fit together properly with the other parts of the replacement device.
Why Were Stryker Knee Replacement Devices Recalled?
A common cause for recall with Stryker knee replacement devices was a defect that could cause the parts of the device to disassociate from each other.
Why Were Smith & Nephew Knee Replacement Devices Recalled?
Smith & Nephew recalled several devices because the revision rate was higher than it should be. Other devices were recalled for other reasons, such as a knee replacement device being packaged with the incorrect screws.
Why Were Corin Knee Replacement Devices Recalled?
Corin recalled several knee replacement devices because the packaging was faulty and allowed water to damage the device.
Why Were Aesculap Impant Systems Knee Replacement Devices Recalled?
Aesculap Implant Systems recalled knee replacement devices due to loosening that resulted in the need for revision surgery.
Why Were Arthrex Knee Replacement Devices Recalled?
Arthrex recalled some knee replacement devices due to an incorrect part number that was listed on the packaging. Other knee replacements were recalled because the texture of the metal’s outer surface was smooth instead of being textured as expected.
Why Were Exactech Knee Replacement Devices Recalled?
Exactech recalled a number of knee replacements, as well as other joint replacement devices due to faulty packaging that exposed polyethylene liners used in the prostheses to the air. This meant that the liners and inserts would break down more quickly than they should, causing patients to need revision surgery sooner than anticipated.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.