PERSONA® Vivacit-E® 42-5121-009-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024469419), received between Apr 22, 2024 and Aug 24, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50415823 ↗
• InjuryMar 20, 2026Failure to Osseointegrate; Detachment of Device or Device Component

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 8 MONTHS POST-IMPLANTATION DUE TO TIBIAL COMPONENT LOOSENING AND PAIN. POSTOPERATIVELY, THE PATIENT DEVELOPED KNEE PAIN, AND AT FOLLOW-UP VISITS THE SURGEON IDENTIFIED PROGRESSIVE TIBIAL COMPONENT LOOSENING ON RADIOGRAPHS WITH MINIMAL TO NO BONE INGROWTH AT THE BONE¿IMPLANT INTERFACE. INTRA-OPERATIVELY DURING THE REVISION, THE TIBIAL COMPONENT WAS CONFIRMED TO BE LOOSE WITH MINIMAL BONE INGROWTH, WAS REMOVED, AND REPLACED WITH A CEMENTED TIBIAL COMPONENT WITH A STEM AND A POLYETHYLENE INSERT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 24647524 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY FOLLOWED BY AN I&D WITH POLY EXCHANGE ONE MONTH POST PROCEDURE. SUBSEQUENTLY, WITHIN A ONE MONTH POST-OPERATIVE TIMEFRAME, THE PATIENT DEVELOPED A DEEP VEIN THROMBUS AND WAS PLACED ON ELIQUIS. DUE TO A REACTION TO ELIQUIS, AN IVC FILTER WAS THEN PLACED AND THE PATIENT WAS REFERRED TO A HEMATOLOGIST FOR CONCERN FOR A BLOOD CLOTTING DISORDER

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19260917 ↗
• InjuryApr 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY FOLLOWED BY A I&D WITH POLY EXCHANGE ABOUT ONE MONTH POST IMPLANTATION FOR INFECTION. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PERSISTENT PAIN AND SWELLING AND UPON ASSESSMENT WAS DIAGNOSED WITH MECHANICAL LOOSENING. TWO YEARS, FIVE MONTHS AFTER THE I&D REVISION THE PATIENT UNDERWENT A REVISION DUE TO ASEPTIC FAILURE. DURING THE REVISION, ENCOUNTERED SYNOVITIS, PITTING TO THE POLY FROM THIRD BODY WEAR, AND DEFECTS NOTED ON THE FEMORAL AND TIBIAL COMPONENTS. ALL COMPONENTS WERE REVISED WITHOUT COMPLICATION.

  Patient problems: Joint effusion; Pain; Synovitis

  MAUDE report 19159425 ↗