PERSONA® Vivacit-E® 42-5221-003-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024468030), received between Mar 7, 2023 and Mar 7, 2023 — classified as 1 injury.

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.

• InjuryMar 7, 2023Unstable; Device-Device Incompatibility; Unstable; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE TO ADDRESS POST-OPERATIVE INSTABILITY AND SWELLING/EFFUSIONS. DURING THE PROCEDURE, IT WAS NOTED THAT THE ARTICULAR SURFACE BEING REMOVED WAS NOT COMPATIBLE WITH THE FEMORAL COMPONENT. THE INSTABILITY IMMEDIATELY RESOLVED WITH A NEW ARTICULAR SURFACE. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Swelling/ Edema

  MAUDE report 16495185 ↗