PERSONA® Vivacit-E® 42-5221-005-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024468184), received between Dec 15, 2020 and Sep 4, 2025 — classified as 4 injuries.

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.

• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, POST-OPERATIVELY REPORTED THE INCISION WAS RED AND WARM TO TOUCH ABOUT NINETEEN DAYS POST PROCEDURE. ISSUE WAS TREATED WITH AN UNKNOWN MEDICATION. ALL PRODUCTS REMAIN IMPLANTED.

  Patient problems: Erythema

  MAUDE report 22968401 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Erythema

  MAUDE report 22957343 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA POST IMPLANTATION DUE TO INCREASED PAIN WITH INTOLERANCE TO EXERCISES AND ARTHROFIBROSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 15925813 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA AND ULTIMATELY UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS STIFFNESS, SCAR TISSUE AND LIMITED RANGE OF MOTION NEARLY THREE MONTHS POST-OPERATIVELY. DURING THE REVISION, SIGNIFICANT FIBROUS TISSUE WAS FOUND THROUGHOUT THE KNEE AND THE PATIENT RECEIVED A SMALLER ARTICULAR SURFACE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 11013322 ↗