PERSONA® Vivacit-E® 42-5224-002-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024243378), received between Sep 12, 2022 and Sep 12, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K121771); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2022Positioning Failure; Positioning Failure

  DURING THE ARTICULAR SURFACE INSERTION, SURGEON TRIED TO IMPLANT A 12MM INSERT HIGH INTO PATIENT. THE INSERT DID LOOK LIKE IT WENT DOWN, HOWEVER IT IS NOT FULLY FLUSHED AND THERE IS NO SOUND. SURGEON TRIED TO INSTALL THE SURFACE MULTIPLE TIMES, HOWEVER IT FAILED. THE INSERT DID NOT FLUSH DOWN ONTO PATIENT EVEN AFTER TRYING TO IMPACT IN. SURGEON INITIAL WANTED A 12MM HEIGHT INSERT INTO PATIENT, HOWEVER IT HAS BEEN CHANGED TO 11MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406501 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121771. 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