PERSONA® Vivacit-E® 42-5221-004-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024468122), received between Mar 23, 2023 and Mar 26, 2026 — 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.

• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FIVE MONTHS POST IMPLANTATION DUE TO INSTABILITY. THE THICKNESS OF THE ARTICULAR SURFACE WAS REDUCED FROM 13MM TO 10MM. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 24700034 ↗
• InjuryOct 30, 2024Adverse 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: Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 20567607 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. PATIENT DID NOT PERFORM THEIR REHABILITATION EXERCISES. SUBSEQUENTLY, PATIENT WAS REVISED APPROXIMATELY SEVEN MONTHS POST-IMPLANTATION DUE TO DECREASED RANGE OF MOTION. THE TIBIAL INSERT WAS REMOVED AND REPLACED.

  Patient problems: Loss of Range of Motion

  MAUDE report 19616589 ↗
• InjuryMar 23, 2023Adverse 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: Adhesion(s); Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 16597989 ↗