PERSONA® Vivacit-E® 42-5221-010-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024468580), received between Apr 28, 2021 and May 21, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE INLAY WAS UNABLE TO BE INSERTED PROPERLY ON THE TIBIAL TRAY. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249540 ↗
• InjuryJul 16, 2024Adverse 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; Scar Tissue

  MAUDE report 19755911 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 10 DAYS POST IMPLANTATION, THE PATIENT WAS DIAGNOSED WITH A DEEP VEIN THROMBOSIS. THE PATIENT WAS PLACED ON ELIQUIS FOR TREATMENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11739253 ↗