PERSONA® Vivacit-E® 42-5121-002-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024468818), received between Jan 7, 2025 and Jan 7, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2025Off-Label Use; Device-Device Incompatibility; Off-Label Use; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, AN INCOMPATIBLE ARTICULAR SURFACE WAS IMPLANTED. THE SURGEON REALIZED THE INCOMPATIBILITY AFTER CEMENTATION OF THE FEMORAL COMPONENT AND TIBIAL TRAY HOWEVER OPTED TO COMPLETE THE OPERATION WITH THE MEDIAL CONGRUENT BEARING. THE PATIENT HAS NOT EXPERIENCED ANY IMPACT OR ADVERSE EVENTS AS A RESULT OF THE INCOMPATIBILITY AND NO ADDITIONAL MEDICAL INTERVENTION IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21096112 ↗