PERSONA® Vivacit-E® 42-5221-004-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024468139), received between Sep 22, 2022 and Jul 15, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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.

• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT'S ARTICULAR SURFACE WAS REVISED APPROXIMATELY ELEVEN AND A HALF MONTHS POST IMPLANTATION DUE TO PATELLA RESURFACING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 22505743 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT¿S ARTICULAR SURFACE WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22297659 ↗
• InjuryFeb 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, A FRACTURE OF THE INLAY IS SUSPECTED AND THE PATIENT IS BEING SCHEDULED FOR A REVISION SURGERY. THE REVISION DATE HAS NOT BEEN SET. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 21423963 ↗
• InjurySep 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE MANIPULATION UNDER ANESTHESIA APPROXIMATELY FORTY DAYS POST-IMPLANTATION DUE TO SCAR TISSUE, PAIN, STIFFNESS, AND LIMITED FLEXION. IT WAS REPORTED RESOLVED THE SAME DAY AND ALL IMPLANTS REMAIN IN PLACE.

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

  MAUDE report 15465085 ↗