When a knee implant causes injuries, the manufacturer can initiate a recall voluntarily or, in rare cases, at the FDA’s request. Unfortunately, for the people who are hurt, recalls often come too late, if at all.
Did you or a loved one suffer complications after receiving a knee replacement? You may be eligible for compensation.
In recent years, several complaints have emerged over knee replacement devices. They include allegations that some popular knee replacement components have failed prematurely or loosened, leading to injuries such as infection, inflammation, and bone or muscle damage. Some knee implant makers have been sued.
These issues can force manufacturers of artificial knee implants to recall products or components. In most cases, a company recalls a medical device on its own when it learns there may a defect. In some instances, a manufacturer will issue a recall after the FDA raises concerns or requests a recall.
A recall of an implanted device, such as an artificial knee, doesn’t always mean that the devices have to be removed (explanted) from a patient. Often, when an implanted device has the potential to fail unexpectedly, companies will tell doctors to contact their patients to go over the risks of removing the device or leaving it in place.
By law, companies must notify the FDA when they correct or remove a product on the market. The agency will then review the strategy the company proposes to address the problem and notify the public.
Once it classifies a recall, the FDA updates its Medical Device Recall Database and notifies the public in its weekly Enforcement Report. The FDA posts separate press releases or public notices for all Class I recalls and some Class II and Class III recalls.
The Medical Device Recall Database is again updated after the FDA terminates or closes a recall.
In 2013, Consumers Union, a nonprofit consumer-advocacy organization, conducted an extensive analysis of knee implant recalls reported to the FDA’s medical device database over the previous 10 years. The organization found a total of 709 knee-implant device or component recalls were issued from February 2003 to May 2013.
Also issuing recalls were Biomet with 75, Smith & Nephew with 11 and Wright with 4. Biomet merged with Zimmer in 2015, creating Zimmer Biomet.
DePuy, a subsidiary of Johnson & Johnson, is one of the largest-joint replacement manufacturers in the world and is known for its High-Flex knee implants: the Sigma CR150 High-Flex Knee System and the Sigma RP-F Knee System.
In December 2017, DePuy recalled all lots of its Sigma HP PFJ Cemented Trochlear Implants. The company discontinued the device as part of its recall. The device was a standalone part used in partial knee replacements. It told surgeons to use an alternative component or consider a total knee replacement.
DePuy had distributed 7,500 of the implants since 2006.
DePuy has issued hundreds of recalls over the years. Between 2003 and 2013, DePuy recalled 277 devices or components, more than any other knee implant manufacturer. The company also had the most FDA Class I recalls — considered the most serious — with four. Another 470 recalls were Class II and three others were Class III recalls.
In 2012, DePuy recalled a number of its custom devices after the FDA warned the company it had failed to seek the agency’s approval for commercial sales.
In February 2013, the FDA issued a recall announcement for DePuy’s LPS Diaphyseal Sleeve, a sleeve component that allows surgeons to correct defects in the knee’s soft tissue and bones. The FDA determined the sleeve may not be able to handle potential physiologic loads during normal patient activities, which could result in fracture of the sleeve at the taper joint and potentially result in loss of function, loss of limb, infection, compromised soft tissue or death.
Prior to the sleeve recall, DePuy recalled its LCS Knee Implant-Meniscal devices because of label errors, which stated the wrong size.
The company also recalled a model sold outside the United States, the LCS Duofix Femoral Component, for more serious reasons. A substance used in manufacturing called alumina had lodged into joint surfaces, causing pain and swelling in patients who received the implant. The product was also linked to increased revision rates, or follow-up surgeries required to adjust or replace implants if they fail.
In 2010, DePuy recalled its PFC Sigma Knee Systems after the FDA warned the products didn’t have proper approvals. The company claimed the products properly bypassed approval procedures because they were custom-made devices, but the FDA disagreed and sent DePuy a warning letter, which led to the recall.
Since 2013, the FDA’s database shows DePuy has issued at least seven recalls of knee implant-related components or surgical tools.
|December 2017||7,500||SIGMA HP PFJ Cemented Trochlear Implants||Elevated revision rates|
|January 2016||351||SIGMA HP MBT Non-Keel Punch Knee Instruments||Design flaw that could cause a delay in surgery|
|September 2015||7,488||Specialist 2 Intramedullary (SP2 IM) Rod||Instrument fracturing during surgery and leaving parts of the rods in patients|
|June 2015||13,964||Attune Knee Tibial Articulation Surface Instruments||Could come off during surgery, leaving a part in device in the patient|
|March 2015||28,732||LCS Complete RPS Inserts||Reports of higher revision surgery rates in Australia|
|November 2014||7,944||Attune Intuition Impaction Handle||Reports of fractures potentially leaving parts in the patient|
|November 2014||4,555||Attune Intuition Impactors||Used along with the impaction handles, the devices could fracture and pieces could be left in the patient|
|February 2014||129||S-ROM Noiles Rotating Hinges||Defective packaging could compromise sterility|
Zimmer Biomet is the largest knee-implant maker in the world. The company took on its present form with the merger of Zimmer and Biomet in 2015. Between the two of them, they had 299 knee implant-related recalls in the Consumers Union analysis.
Prior to the merger, Zimmer initiated 224 recalls of its knee-replacement systems between 2003 and 2013. All but one were Class II recalls and the remaining recall was a Class III. Zimmer manufactures numerous knee components including the Persona Knee System and the NexGen MIS Tibial Component.
Prior to its merger with Zimmer, Biomet issued 75 knee implant-related recalls between 2003 and 2013. All were Class II recalls.
In 2007, Biomet recalled its Vanguard PS Open Box Femoral Component because it was mislabeled. In 2008, the company issued another recall for the Vanguard DCM PS Plus Tibial Bearing implant because the sizing information was incorrect.
Zimmer recalled nearly 70,000 MIS Tibial Components in 2010 after reports indicated the component’s locking screws and stem extensions failed to interlock correctly.
The company has recalled more than 50 knee implant-related tools and components since 2013. Some of them have involved thousands of units.
In 2014, 40,000 Zimmer NexGen knee implants with defective screws were recalled and in 2015, Zimmer recalled all lots and sizes of a component of its Persona Knee line of implants. The Class II recall involved all lots and sizes — more than 11,000 in total — of the Persona Trabecular Metal Tibial Plate knee implant. The FDA warned the component could loosen and cause complications.
In January 2017, following their merger, Zimmer Biomet issued a Class II recall for its Vanguard Total Knee System because of mislabeling and packaging problems. The recall affected 15,000 products on the market in the U.S. and 21 other countries.
Zimmer said there was no immediate threat to patients, but long-term exposure could lead to inflammation or other tissue reactions around the implant. In the worst cases, this could lead to aseptic loosening of the implant requiring revision surgery.
The company’s recall notice included a 13-page list of the lot numbers affected.
Zimmer still faces hundreds of lawsuits related to high failure rates of NexGen implants. Those cases are consolidated into multidistrict litigation (MDL) in the Northern District of Illinois.
Of Stryker’s 118 recalls between 2003 and 2013, there was one Class I, 95 were Class II and 22 Class III. More than two-thirds were implanted rather than procedural devices. Damaged components and early wear of tibial inserts were among the most common reasons for the recalls.
In January 2012, Stryker Orthopaedics recalled 26,000 of its EIUS Unicompartmental Knee Systems over higher revision rates. The recall came several years after the FDA warned Stryker about procedural problems at joint manufacturing facilities in Ireland and New Jersey. The 2007 warning letters targeted two knee-replacement components — the Duracon and the Scorpio — and other joint components.
The recall was due to software defects that resulted in wider cutting ranges and displayed parameters that may not have matched the guides produced, including the depth of resection and the angle of the cut.
Prior to the recall, the FDA received 44 reports of incidents related to the ShapeMatch guides, which stopped being available on the market in November 2012.
Stryker agreed to pay $80 million in 2014 to resolve criminal and civil liability related to faulty cutting guides used for knee-replacement surgeries. The guides were a product of OtisMed Corporation, a subsidiary of Stryker.
Since 2013, Stryker has issued at least seven more recalls for components or tools related to its knee implants.
|August 2016||2,039||Stryker Orthopaedics Patella Assembly Instruments||Parts could disassociate with an accompanying instrument during surgery|
|June 2016||12,469||Stryker Orthopaedics Modular Handle Triathlon Instruments||Parts could become disassociated from the rest of the instrument|
|September 2015||3,444||MIS Modular Distal Capture Triathlon Instruments||Reports that parts could potentially disassociate from the instruments|
|August 2014||1,147||Triathlon Femoral Components||Packaging issue that could affect the shelf life of the devices’ sterility|
|August 2014||1,147||Scorpio Femoral Components||Same packaging issue as the Triathlon components, potentially affecting the components’ sterility|
Between 2003 and 2013, Smith & Nephew had 11 knee implant-related recalls, all Class II. The UK-based medical device manufacturer’s knee-implant product line includes devices branded in its Journey, Genesis and Legion series.
In 2003, Smith & Nephew recalled its Oxinium Genesis II and Oxinium Profix II knee devices after reports of pain, loosening and revision surgeries. In 2008, the company recalled its TC-PLUS, VKS and RT-PLUS knee models because the implants contained higher-than-specified levels of iron.
In 2010, Smith & Nephew recalled Journey Uni Tibial Baseplate knee components because the base plates and inserts were prone to breaking.
|May 2017||46||Legion Tib Cone Impactor Heads||The wrong adhesive was used to assemble them|
|March 2016||Various Sizes||TC-Plus Primary Tibial Components||A manufacturing defect that could make the polyethylene insert difficult or impossible to seat during surgery|
|January 2016||8||Legion Hemi Stepped, Tibial Screw-On Wedges||Screws were too long|
Wright Medical sold its hip and knee division to Corin Orthopaedics in 2016 for a reported $290 million and is no longer a major player in the knee-implant business. But between 2003 and 2013, the company issued four recalls, all Class II.
A search of the FDA medical device recall database turned up no recalls for knee implant-specific components or surgical tools issued by Wright Medical after the 2013 Consumers Union analysis was published.
Please seek the advice of a medical professional before making health care decisions.
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