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Knee Replacement Recalls

Manufacturers issue voluntary knee replacement recalls if they discover problems with the devices. In rare cases, the U.S. Food and Drug Administration can order a recall. Manufacturers issued hundreds of knee replacement recalls in recent years. Drugwatch identified 74 knee implant recalls between 2013 and May 2018.

Complications after a Knee Replacement?

Did you or a loved one suffer complications after receiving a knee replacement? You may be eligible for compensation.

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Five manufacturers accounted for 983 knee replacement recalls since 2003. The recalls included implants and tools for knee replacement surgery.

The U.S. Food and Drug Administration keeps track of knee recalls.

The nonprofit consumer-advocacy organization Consumers Union reviewed knee recalls in 2013. It identified 709 recalls in the FDA database between 2003 and 2013.

Drugwatch identified another 74 recalls since the report’s release and May 2018.

Manufacturers and Knee Replacement Safety

Knee implant manufacturers are responsible for appropriate marketing of their products. They must warn consumers and health care professionals about their devices’ risks.

Manufacturers are also responsible for monitoring their products for problems after FDA approval. But critics argue that the FDA approval process does not do enough to keep unsafe devices off the market.

Complications after a Knee Replacement? Get a Free Case Review

Manufacturers often rely on the agency’s Premarket Notification process. This is also called the 510(k) process.

It lets knee replacement makers skip more rigorous tests. They only have to show their device is “substantially equivalent” to similar products.

Knee replacement lawsuits blame manufacturers for selling defective devices.

Reasons for Knee Replacement Recalls

Manufacturers issue knee replacement recalls for several reasons. These can be as simple as faulty packaging on knee replacement parts. Or they can involve defective parts that pose a risk of serious injuries.

Knee Replacement Recall Issues
Faulty design
Implants and tools were prone to fracture. Tools had flawed designs or sometimes fell into the surgical site
Improper fit
Implants could suffer damage when surgeons forced a component into place
Loosening
Patients needed revision surgery because knee replacements loosened
Early wear
Parts wore out sooner than expected
Packaging errors
Faulty packages compromised surgical tools’ sterility
Co-mingled components
Parts of the left and right knee replacements became mixed together. This caused confusion during surgery
Knee Replacement Inflammation as Seen on X-Ray
Premature knee replacement loosening can lead to infection, inflammation and pain.

Manufacturers with the Most Knee Replacement Recalls

Three manufacturers account for the majority of knee replacement recalls since 2003.

DePuy Synthes accounted for almost half of those.

Two other companies combined for only 15 recalls between them.

Knee Recalls by Manufacturer, 2003 - 2018
Knee Replacement Manufacturer Knee Recalls
DePuy Synthes 485
Zimmer Biomet* 355
Stryker 125
Smith & Nephew 14
Wright Medical** 4
Percentage of Knee Recalls, 2003 - 2018
Expand
*Combines recalls by both Zimmer and Biomet before the companies merged in 2015.
**Wright sold off its hip and knee replacement business in 2016. It no longer makes knee replacement implants.

DePuy Knee Replacement Recalls

DePuy Synthes has issued hundreds of recalls over the years.

One of the most recent was in December 2017 for Sigma knee components. The devices had higher than expected failure rates.

DePuy also recalled almost 14,000 Attune knee surgical tools in 2015.

The FDA’s database shows at least six other DePuy knee replacement recalls since 2013.

Between 2003 and 2013, DePuy issued at least 477 knee replacement-related recalls. That’s more than any other knee implant manufacturer.

DePuy Knee Implant-Related Recalls
Date Amount Device Type Reason
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 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 Knee Replacement Recalls

Zimmer Biomet has issued at least 355 knee replacement-related recalls since 2003.

One of the most recent was in 2017 for more than 28,000 joint components. Inspections found elevated endotoxin levels on the parts.

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.

Recent Zimmer Biomet Knee Replacement Recalls
Date Units Device Type Reason
November 2017 13,227 Gender Solutions Patello-Femoral Joint System Packaging problems
November 2017 1023 Persona Partial Knee instruments Spacer blocks do not fit in the alignment tower instrument or handle
October 2017 430 Persona Partial Knee Spacer Blocks Problems with flexion in range-of-motion trials
February 2017 28,000 Zimmer Biomet polyethylene joint components Elevated endotoxin levels
January 2017 15,000 Vanguard Total Knee System Mislabeling and packaging problems
May 2016 10,256 Persona Trabecular Metal Tibial Plate Knee implants Implant loosening
January 2016 42,064 Zimmer NexGen Knee implants Packaging could adhere to implant parts

Stryker Knee Replacement Recalls

Stryker issued 125 knee replacement-related recalls since 2003.

In 2016, the company issued two recalls affecting 14,000 surgical instruments.

Stryker Components or Tool Related Recalls:
Date Amount Device Type Reason
August 2016 2,039 Stryker Orthopaedics Patella Assembly Instruments Parts could come apart from an accompanying instrument during surgery
June 2016 12,469 Modular Handle Triathlon Instruments Parts could come apart from the rest of the instrument
September 2015 3,444 MIS Modular Distal Capture Triathlon Instruments Reports that parts could come apart from the instruments
August 2014 1,147 Triathlon Femoral Components Packaging issue could affect the shelf life of the devices’ sterility
August 2014 1,147 Scorpio Femoral Components Packaging issue could affect the shelf life of the devices’ sterility

Smith & Nephew Knee Replacement Recalls

Smith and Nephew announced 14 knee replacement-related recalls since 2003.

At least three happened since the 2013 Consumer Union analysis.

The most recent recalls affected fewer than 100 total units.

Date Amount Device Type Reason
May 2017 46 Legion Tib Cone Impactor Heads The wrong adhesive used in assembly
March 2016 24 TC-Plus Primary Tibial Components Manufacturing defect; it 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 Knee Replacement Recalls

Wright Medical announced four knee replacement recalls since 2003. Drugwatch found none after 2013.

Wright sold its hip and knee division to Corin Orthopaedics in 2016 for a reported $290 million.

Wright is no longer a major player in the knee-implant business.

Please seek the advice of a medical professional before making health care decisions.

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15 Cited Research Articles

  1. U.S. Food and Drug Administration. (2018, March 23). What is a Medical Device Recall? Retrieved from https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm329946.htm
  2. Gann, C. (2012, February 10). Knee Replacements Double in 10 Years. Retrieved from http://abcnews.go.com/m/blogEntry?id=15557221&sid=26&cid=26
  3. U.S. Food and Drug Administration. (2012, January 11). Class 2 Device Recall Eius Unicompartmental Knee System. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=106058
  4. Meier, B. (2010, June 20). Surgeon vs. Knee Maker: Who’s Rejecting Whom? Retrieved from http://www.nytimes.com/2010/06/20/business/20knee.html
  5. U.S. Judicial Panel on Multidistrict Litigation. 2015, April 3). In Re Zimmer NexGen Knee Implant Products Liability Litigation, MDL No. 2272, Transfer Order. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2272-Tag-Along-Transfer-03-15.pdf
  6. Gibbs, G. (2003, September 18). Knee implant recall hits Smith & Nephew. The Guardian. Retrieved from http://www.theguardian.com/business/2003/sep/18/6
  7. DePuy Synthes. (2017, December). Urgent Field Safety Notice (Recall). Retrieved from https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2018/00143-18_kundeninfo_en.pdf;jsessionid=CD5D3742F6BB4C481804F1AD461D383A.2_cid354?__blob=publicationFile&v=1
  8. Perriello, B. (2018, January 17). Revision Rates Prompt Recalls for Johnson & Johnson’s DePuy Synthes, Zimmer Biomet. Mass Device. Retrieved from https://www.massdevice.com/revision-rates-prompt-recalls-johnson-johnsons-depuy-synthes-zimmer-biomet/
  9. Consumers Union. (2013, September 9). A Summary of Knee Recalls Consumers Union Safe Patient Project. Retrieved from http://safepatientproject.org/wordpress/wp-content/uploads/2013/09/Knee-Recall-Summary-final-9-9-13.pdf
  10. U.S. Food and Drug Administration. (2013, February 22). Class 1 Device Recall LPS Diaphyseal Sleeves Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=114764
  11. U.S. Food and Drug Administration. (2017, January 28). Class 2 Device Recall Vanguard Total Knee System. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151861
  12. Smith & Nephew. (2017). Annual Report 2016. Retrieved from: http://www.smith-nephew.com/global/assets/pdf/corporate/smith_nephew_annual_report_2016_interactive.pdf
  13. Zimmer Biomet. (2017, February 17). Medical Device Recalls. Retrieved from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=154239&CREATE_DT=2017-03-27
  14. Sheffield, M. (2016, October 24). Wright Medical Sells Hip/Knee Division. Memphis Business Journal. Retrieved from: https://www.bizjournals.com/memphis/news/2016/10/24/wright-medical-sells-hip-knee-division.html
  15. FDA. (n.d.). Medical Device Recalls (Accessed May 9, 2018). Retrieved from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm
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