PERSONA® Vivacit-E® 42-5120-002-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024234901), received between Jan 27, 2022 and Oct 18, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K121771, K172524); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2023Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO METALLOSIS AND OSTEOLYSIS. DEBRIDEMENT WAS PERFORMED. THE ARTICULAR SURFACE WAS REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 17956390 ↗
• MalfunctionJan 27, 2022Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT A SURGEON FAILED TO INSERT AN ARTICULAR SURFACE DURING A PROCEDURE. THE SURGEON CONFIRMED THAT THE POSTERIOR CENTRAL SLIT ON THE BACKSIDE OF THE ARTICULAR SURFACE WAS SLIGHTLY DEFORMED. SUBSEQUENTLY, AN 11MM ARTICULAR SURFACE WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366445 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121771, K172524. One submission often covers many models, so check the product and lot details in each record.

• Z-1917-2016 · May 11, 2016 · Terminated
  Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
• Z-1266-2015 · Jan 28, 2015 · Terminated
  Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in eit