PERSONA® Vivacit-E® 42-5122-005-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024236523), received between Dec 23, 2020 and Jun 9, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information

  MAUDE report 22169960 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL BILATERAL KNEE ARTHROPLASTY. THE PATIENT REPORTS CHRONIC ISSUES WITH BOTH KNEES INCLUDING PAN AND SWELLING. THE PATIENT HAD AN MRI WITH FINDINGS OF BONE NECROSIS, QUADRICEPS AND PATELLA TENDINOSIS, PATELLAR TENDON PERFORATION, AND MODERATE EFFUSION. THE DEVICES REMAIN IMPLANTED AT THIS TIME.

  Patient problems: Inflammation; Muscle/Tendon Damage; Necrosis; Pain

  MAUDE report 21245556 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT UNDERWENT A POLY SWAP DUE TO ARTHROFIBROSIS. PATIENT HAD BETTER RANGE OF MOTION FOR A TIME BUT THEN IT DECREASED DUE TO FIBROUS TISSUE BUILDUP. A FURTHER REVISION WAS PERFORMED TO REMOVE THE ENTIRE KNEE AND REPLACE WITH A REVISION SYSTEM. NO FURTHER PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Adhesion(s); Fibrosis; Scar Tissue

  MAUDE report 19214881 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Loss of Range of Motion; Osteopenia/ Osteoporosis; Pain

  MAUDE report 16052307 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PATELLA AND MEDIAL LIGAMENT INSTABILITY APPROXIMATELY NINETEEN (19) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 12778657 ↗
• InjuryApr 7, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: Loss of Range of Motion; Muscular Rigidity; Scar Tissue

  MAUDE report 11631207 ↗
• MalfunctionDec 23, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT UNKNOWN FLAKES OF FOREIGN MATERIAL WERE FOUND INSIDE THE STERILE PACKAGING OF AN ARTICULAR SURFACE. SURGICAL PROCEDURE WAS DELAYED BY TWO MINUTES. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 11064790 ↗

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