PERSONA® Vivacit-E® 42-5220-004-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024241596), received between Apr 22, 2024 and Apr 22, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 reports).

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.

• MalfunctionApr 22, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A TOTAL KNEE ARTHROPLASTY WAS PERFORMED AND THE FIRST ARTICULAR SURFACE DIDN'T MATE WITH TIBIAL PLATE ALTHOUGH THE SURGEON CONFIRMED NO INTERVENTION OF CEMENT PARTICLES, SOFT TISSUE, OR BONE SPURS BETWEEN THE SURFACE AND THE TIBIAL PLATE. HE INSERTED THE SURFACE WITH THE INSERTER MANY TIMES, HOWEVER, THE SURFACE MOVED BACK TO THE FRONT. A SECOND POLY OF THE SAME SIZE WAS TRIED WITH THE SAME TIBIAL PLATE, BUT THE SAME PROBLEM OCCURRED. AS A RESULT, THE OPERATION WAS COMPLETED WITH A SMALLER POLY. THERE WAS A 16-30 MINUTE DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19155431 ↗
• MalfunctionApr 22, 2024Positioning Failure; Positioning Failure

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19155417 ↗

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