PERSONA® Vivacit-E® 42-5220-005-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024241664), received between Mar 3, 2022 and Jun 10, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO INFECTION. THE TIBIAL INSERT WAS REMOVED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 19499602 ↗
• InjuryMar 3, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT UNDERWENT A RIGHT KNEE REVISION ARTHROPLASTY APPROXIMATELY NINE YEARS POST IMPLANTATION DUE TO PAIN AND ASEPTIC LOOSENING OF FEMORAL COMPONENT. AT TIME OF REVISION, THE FEMORAL COMPONENT WAS LOOSE AND EASILY REMOVED, THE TIBIA APPEARED WELL FIXED. INSPECTION OF ARTICULAR SURFACE REVEALED DAMAGE TO THE POST. THERE WAS RESIDUAL CEMENT PRESENT IN THE FEMORAL NOTCH. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 13660130 ↗

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