Knee Replacement Recalls

Knee replacement recalls have been issued because of loosening, early wear or faulty packaging. Nearly 1,000 implant parts used in knee surgeries have been affected by DePuy, Zimmer-Biomet and Stryker knee replacement recalls. Lawsuits blame manufacturers for selling defective devices.

Last Modified: March 30, 2021
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The advocacy group Consumers Union reviewed the FDA’s medical device database and found that 708 knee replacement recalls were issued between 2003 and 2018. Drugwatch conducted a separate review in 2018 and identified another 76 recalls. Roughly 97 percent of all recalls during that timeframe involved knee replacements from just three manufacturers: Zimmer-Biomet, DePuy and Stryker.

The recalls included nearly 250,000 package and label issues, knee implant parts and tools used in knee replacement surgery from 2014 through 2017 alone.

Smith & Nephew recalled more than 42,000 Journey I BCS Knee Systems in 2018 after joint registries in the United Kingdom and Australia — which collect data on joint replacement surgeries to improve patient care — reported the device’s revision surgery rates were 1.5 times that of the average for all knee replacements.

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.

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 recall
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 the total recalls.

Two other companies combined for only 19 recalls between them.

Knee Recalls by Manufacturer, 2003 - 2018
Knee Replacement Manufacturer Knee Recalls
DePuy Synthes 485
Zimmer Biomet* 355
Stryker 125
Smith & Nephew 15
Wright Medical** 4
Percentage of Knee Replacement 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. But to date, there have been no recalls of Attune Knee implants.

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
DateAmountDevice TypeReason
December 20177,500SIGMA HP PFJ Cemented Trochlear ImplantsElevated revision rates
January 2016351SIGMA HP MBT Non-Keel Punch Knee InstrumentsDesign flaw that could cause a delay in surgery
September 20157,488Specialist 2 Intramedullary (SP2 IM) RodInstrument fracturing during surgery and leaving parts of the rods in patients
June 201513,964Attune Knee Tibial Articulation Surface InstrumentsCould come off during surgery, leaving a part in device in the patient
March 201528,732LCS Complete RPS InsertsReports of higher revision surgery rates in Australia
November 20147,944Attune Intuition Impaction HandleReports of fractures potentially leaving parts in the patient
November 20144,555Attune Intuition ImpactorsCould fracture and pieces could be left in the patient
February 2014129S-ROM Noiles Rotating HingesDefective 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
DateUnitsDevice TypeReason
November 201713,227Gender Solutions Patello-Femoral Joint SystemPackaging problems
November 20171023Persona Partial Knee instrumentsSpacer blocks do not fit in the alignment tower instrument or handle
October 2017430Persona Partial Knee Spacer BlocksProblems with flexion in range-of-motion trials
February 201728,000Zimmer Biomet polyethylene joint componentsElevated endotoxin levels
January 201715,000Vanguard Total Knee SystemMislabeling and packaging problems
May 201610,256Persona Trabecular Metal Tibial Plate Knee implantsImplant loosening
January 201642,064Zimmer NexGen Knee implantsPackaging could adhere to implant parts

Stryker Knee Replacement Recalls

There have been 125 Stryker knee replacement recalls since 2003.

Stryker voluntarily recalled its ShapeMatch Cutting Guides after patients reported injuries. These instruments were meant to help surgeons position the Stryker Triathlon knee implant before the bone was cut, but complaints submitted to the FDA allege the device was misaligned, which caused such complications as joint instability, chronic pain and revision surgery. The FDA later classified it as a Class I recall in April 2013.

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

Stryker Components or Tool Related Recalls:
DateAmountDevice TypeReason
August 20162,039Stryker Orthopaedics Patella Assembly InstrumentsParts could come apart from an accompanying instrument during surgery
June 201612,469Modular Handle Triathlon InstrumentsParts could come apart from the rest of the instrument
September 20153,444MIS Modular Distal Capture Triathlon InstrumentsReports that parts could come apart from the instruments
August 20141,147Triathlon Femoral ComponentsPackaging issue could affect the shelf life of the devices’ sterility
August 20141,147Scorpio Femoral ComponentsPackaging issue could affect the shelf life of the devices’ sterility
April 20137,868ShapeMatch Cutting GuideDevice misalignment could result in knee implants being placed in the wrong position

Smith & Nephew Knee Replacement Recalls

Smith and Nephew has announced 15 knee replacement-related recalls since 2003.

The 2018 recall of the Journey I BCS Knee System affected more than 42,000 units, according to the FDA.

The following Journey I BCS femoral component products were named in the recall:
  • JOURNEY BCS CoCr Femoral Component
  • JOURNEY BCS Oxinium Femoral Component
  • JOURNEY BCS Tibial Insert

Previous Smith & Nephew recalls involved fewer than 100 total units.

Smith & Nephew Components or Tool Related Recalls:
DATEAMOUNT DEVICE TYPEREASON
June 201842,050Journey I BCS Knee SystemHigher than normal revision rates because of early component loosening and other problems
May 201746Legion Tib Cone Impactor HeadsThe wrong adhesive used in assembly
March 201624TC-Plus Primary Tibial ComponentsManufacturing defect; it could make the polyethylene insert difficult or impossible to seat during surgery
January 20168Legion Hemi Stepped Tibial Screw-On WedgesScrews 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.

Arthrex Inc. Knee Replacement Recalls

Arthrex has issued two recalls related to its iBalance knee replacement line: one for the iBalance Total Knee Arthroplasty System and another for the iBalance Unicondylar Knee Arthroplasty System.

Arthrex, Inc. Knee Implant Component Recalls:
DateAmountDevice TypeReason
December 20152,378Arthrex iBalance TKA Tibial TrayOuter metal surface was smooth compared to previous textured components
October 201720iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERALIncorrect part number printed on label
Please seek the advice of a medical professional before making health care decisions.