PERSONA® Vivacit-E® 42-5121-008-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024469341), received between Mar 27, 2023 and Feb 25, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Difficult to Insert

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE ARTICULAR SURFACE WOULD NOT LOCK INTO PLACE. ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443860 ↗
• MalfunctionNov 7, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON WAS PREPARING THE FEMUR FOR A SIZE 8 COMPONENT, HOWEVER, THIS WAS DETERMINED TO BE TOO LARGE SO THE TEAM DOWNSIZED TO A SIZE 7 FEMORAL COMPONENT AND COMPLETED THE CASE. SUBSEQUENTLY, DURING CLOSING, THE SURGEON WAS NOTIFIED THAT THEY IMPLANTED THE WRONG POLY AS THE POLY USED WAS SUPPOSED TO BE IMPLANTED WITH THE LARGER FEMORAL COMPONENT. THE PATIENT HAS NOT EXPERIENCED ANY ISSUES SINCE THE SURGERY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496294 ↗
• InjuryMay 27, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REQUIRED LEFT KNEE REVISION TWO YEARS, SEVEN MONTHS POST IMPLANTATION DUE TO PAIN, INSTABILITY, AND VARUS/VALGUS JOINT LAXITY. THE POLY AND FEMORAL COMPONENTS WERE REVISED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22087316 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. APPROXIMATELY 7 DAYS POST IMPLANTATION, THE PATIENT PRESENTED TO THEIR PRIMARY CARE PROVIDER AND WAS DIAGNOSED WITH DEEP VEIN THROMBOSIS. MEDICATION WAS GIVEN AS TREATMENT AND THIS WAS RESOLVED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21055676 ↗
• MalfunctionMar 27, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE WOULD NOT IMMEDIATELY SEAT ONTO THE TIBIAL TRAY DURING IMPLANTATION. THE SURGEON WAS ABLE TO SEAT THE BEARING WITH SOME IMPACTION. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618299 ↗