PERSONA® Vivacit-E® 42-5121-004-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024468986), received between Apr 19, 2021 and Apr 21, 2026 — classified as 8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY FOUR MONTHS POST IMPLANTATION DUE TO INFECTION. DURING THE PROCEDURE THE SURGEON NOTICED SOME PITTING IN THE BEARING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Medical device site infection; Septic loosening

  MAUDE report 24936960 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 23942941 ↗
• InjuryNov 10, 2025Adverse 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: Crepitus; Extraskeletal ossification; Numbness; Pain

  MAUDE report 23509592 ↗
• MalfunctionNov 3, 2025Difficult to Insert; Difficult to Insert

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23449718 ↗
• MalfunctionFeb 5, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE WHILE PREPARING THE IMPLANTS FOR USE, SIGNIFICANT DEFORMATION WAS OBSERVED IN THE PACKAGING OF BOTH THE INNER AND OUTER BLISTERS. IT WAS NOT POSSIBLE TO RULE OUT IF THE STERILE SEAL WAS COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315325 ↗
• InjuryFeb 4, 2025Adverse 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: Loss of Range of Motion; Pain

  MAUDE report 21306930 ↗
• InjuryNov 25, 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: Ambulation or Postural Difficulties; Loss of Range of Motion; Scar Tissue

  MAUDE report 20770454 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT REPORTED DIZZINESS, NAUSEA, FATIGUE, SHORTNESS OF BREATH, AND HYPOTENSION ABOUT THREE WEEKS POST TKA. THE PATIENT AND WAS TRANSFERRED TO THE EMERGENCY ROOM VIA EMS. A CT SCAN CONFIRMED A NONOCCLUSIVE SUB-SEGMENTAL PULMONARY EMBOLISM WITH LEFT UPPER LOBE AND WAS HOSPITALIZED FOR TWO DAYS FOR ANTICOAGULATION THERAPY. THE PATIENT WAS DISCHARGED HOME TWO DAYS LATER, PRESCRIBED ON APIXABAN FOR THREE MONTHS. AT THE THREE MONTH FOLLOW-UP, THE PATIENT WAS PROGRESSING WELL AND REMAINED SATISFIED WITH ALL IMPLANTS IN PLACE.

  Patient problems: Dizziness; Dyspnea; Fatigue; Low Blood Pressure/ Hypotension; Nausea; Pulmonary Embolism

  MAUDE report 19911534 ↗
• InjuryAug 31, 2021Adverse 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: Muscle/Tendon Damage; Pain

  MAUDE report 12390958 ↗
• MalfunctionAug 12, 2021Difficult to Insert; Difficult to Insert

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313489 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS APPROXIMATELY 2 MONTHS LATER. THE ISSUE RESOLVED, AND THE PATIENT HAD FULL RANGE OF MOTION WITH NO COMPLAINTS AT THE NEXT FOLLOW UP VISIT. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 11685882 ↗