PERSONA® Vivacit-E® 42-5222-006-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024243149), received between Oct 8, 2019 and Jun 27, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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.

• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD REVISION SURGERY DUE TO UNKNOWN REASONS ABOUT FIVE YEARS POST IMPLANTATION. ACCORDING TO STICKER SHEET, THE FEMUR AND ARTICULAR SURFACE WERE EXCHANGED. PREVIOUSLY, ON AN UNKNOWN DATE ABOUT TWO YEARS PRE REVISION, THE PATIENT RECEIVED A WASHOUT WITH BIOPSIES. NO OPERATIVE OR FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22344548 ↗
• InjuryOct 8, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF THE KNEE DUE TO TIBIAL LOOSENING AND POLY WEAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Information

  MAUDE report 9167207 ↗

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