PERSONA® Vivacit-E® 42-5222-004-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024242968), received between May 25, 2022 and May 25, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, UNDERWENT A MANIPULATION, UNDER ANESTHESIA OF THE RIGHT KNEE TWO MONTHS POST PROCEDURE, DUE TO ARTHROFIBROSIS OF THE JOINT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT DEMONSTRATED OVERALL IMPROVEMENT WITH PAIN, SATISFACTION, AND QUALITY OF LIFE AND COMPLETED THE STUDY PER PROTOCOL WITH NO FURTHER INTERVENTIONS.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 14496232 ↗

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