PERSONA® Vivacit-E® 42-5121-003-12 (UDI 00889024468917)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024468917), received between Feb 21, 2023 and Mar 4, 2026 — classified as 3 injuries, 1 malfunction.

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

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMETLY 2 YEARS POST IMPLANTATION DUE TO INSTABILITY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Joint Laxity

  MAUDE report 24512365 ↗
• MalfunctionJun 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS A HAIR ON THE IMPLANT WHEN THE LEFT MC BEARING IMPLANT WAS OPENED. THE IMPLANT WAS WASHED WITH SALINE AND THEN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318474 ↗
• InjuryJul 25, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR THREE AND A HALF MONTHS POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Fall; Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 17387979 ↗
• InjuryFeb 21, 2023Pitted; Naturally Worn; Pitted; Naturally Worn

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

  Patient problems: Failure of Implant

  MAUDE report 16407900 ↗