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Zimmer Persona Knee Replacement Recalls

The Uncemented Trabecular Metal Tibial Plate and Tibial Articular Surface Provisional Shim Tool are Persona Knee implant products which Zimmer recalled following reports of adverse events.

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Zimmer Inc., an orthopedics device manufacturer based in Warsaw, Indiana has recalled a key component used in its knee resurfacing and replacement product, the Zimmer Persona Personalized Knee System. That component is the porous coated, uncemented Zimmer Persona Trabecular Metal Tibial Plate. 1

Trabecular Metal Tibial Plate Recall

In February 2015, Zimmer ceased shipping the Zimmer Persona Personalized Knee System’s porous coated, uncemented Trabecular Metal Tibial Plate and voluntarily withdrew it from the market. In March 2015, the U.S. Food and Drug Administration categorized that recall as a Class II. 2

The FDA approved the Zimmer Persona Personalized Knee System for marketing within the U.S. in 2012. Zimmer obtained that approval using the FDA’s expedited 510(k) application process.

The 510(k) process allows a device maker to bring a new product to market without first subjecting it to as rigorous clinical testing as is required for “pre-market approval” (PMA) devices. To do so requires that the new product is substantially similar to another product already approved by the FDA. 3

Zimmer initiated its recall after multiple event reports were submitted to the FDA and appeared in the FDA’s MAUDE database. Many of those reported events involved device loosening or lines on X-ray film.

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Tibial Articular Surface Provisional Shim Tool

Additionally, Zimmer recalled its Persona Tibial Articular Surface Provisional Shim Tool. The date of Zimmer’s URGENT MEDICAL DEVICE CORRECTION NOTIFICATION was December 11, 2014, with the FDA classifying this recall as Class II on February 4, 2015. 4

More than 67,000 shim tools were included in this recall, which required that to prevent this from happening, the Tibial Articular Surface Provisional shims must be manually cleaned and inspected per a new product insert.

The Zimmer Persona Tibial Articular Surface Provisional Shim Tool’s purpose is to be used during surgery for determinations regarding range-of-motion and implant thickness requirements. The problem with this instrument, stated in the URGENT MEDICAL DEVICE CORRECTION, is that there is potential for a ball bearing and /or spring to eject during surgery, causing a potential for delay in surgery, and/or a missing part to be left in the surgical wound.

Zimmer claimed that its investigation found that repeated cycles using sonic cleaning can break down the ball bearing retention “swage” on the shim tool.

More than 67,000 shim tools were included in this recall, which required that to prevent this from happening, the Tibial Articular Surface Provisional shims must be manually cleaned and inspected per a new product insert.

Surgical Revisions Needed for Persona Knee Replacement

As of early March 2015, as indicated in the MAUDE database, there were several reports of revision submitted to the FDA regarding Zimmer Persona knee implants. The cited reasons why the revision surgeries became necessary were varied and included:

  • Loosening of the device
  • Persistent pain
  • Tibial component failure
  • Lack of ingrowth
  • Wear
  • Globally tight knee
  • Component fixation loss
  • Instability
  • Patella tracking problems
  • Fracture

Persona Lawsuits and Complaints

Any lawsuits arising from these recalls will more than likely seek to hold Zimmer liable for damages on a variety of legal theories including, but not limited to, strict liability in tort, defective design, negligence, breach of warranty and violation of consumer-protection laws.

In future potential lawsuits, plaintiffs may seek compensation from Zimmer for the money spent on revision surgery and related care during recovery; for the loss of wages during the period when the device, the surgery and the recovery prevented them from working; and for other harms actually and proximally connected to the Zimmer Persona Trabecular Metal Tibial Plate or  Tibial Articular Surface Provisional Shim Tool.

  1. Zimmer Persona: The Personalized Knee System Surgical Technique, 2014 

  2. Fierce Medical Devices, “Zimmer recalls part of Persona — a total knee replacement that helped drive 2014 growth,” March 134, 2015,
    http://www.fiercemedicaldevices.com/story/zimmer-recalls-part-persona-total-knee-replacement-helped-drive-2014-growth/2015-03-13. U.S. Food and Drug Administration, Class 2 Device Recall Persona Trabecular Metal Tibial Plate / Persona TM Tibia. March 12, 2015. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=133978 

  3. U.S. Food and Drug Administration, Premarket Approval (PMA)
    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm2007514.htm, U.S. Food and Drug Administration , 510(k) Clearances. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ 

  4. U.S. Food and Drug Administration, Class 2 Device Recall Persona Tibial Articular Surface Provisional Shim. February 04, 2015.