Persona® Vivacit-E® 42-5228-007-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024555310), received between Jun 2, 2022 and Aug 26, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

1 other recall cover devices cleared under the same FDA submission (K181947, K191625); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THE PATIENT UNDERWENT REVISION DUE TO THE SCREW USED TO LOCK DOWN THE ARTICULAR SURFACE DISASSOCIATED(BACKED OUT). ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN PERFORMED AND NONE HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20063794 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A TOTAL KNEE REVISION 4 YEARS POST IMPLANTATION DUE TO INFECTION. AN ADDITIONAL REVISION OF THE PATELLAR COMPONENT TOOK PLACE APPROXIMATELY 18 MONTHS POST PROCEDURE DUE TO ASEPTIC LOOSENING. SUBSEQUENTLY, THE PATIENT REPORTED AN ONSET OF ANTERIOR KNEE PAIN THAT BEGAN 8 MONTHS AFTER THE PATELLA REVISION.

  Patient problems: Ambulation or Postural Difficulties; Joint Contracture; Pain

  MAUDE report 19119381 ↗
• MalfunctionJul 18, 2023Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341628 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND TENDERNESS OF THE PES ANSERINUS AND ILIOTIBIAL TRACT REQUIRING A CORTISONE INJECTION TWO YEARS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Bursitis; Loss of Range of Motion; Pain

  MAUDE report 14582652 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181947, K191625. One submission often covers many models, so check the product and lot details in each record.

• Z-2578-2026 · May 11, 2026 · Open, Classified
  Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: