PERSONA® Vivacit-E® 42-5121-010-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024469471), received between May 14, 2024 and Aug 18, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient in a clinical study underwent an initial left total knee arthroplasty and subsequently required a cortisone injection and topical cream for iliotibial band tenderness approximately 3 months post-implantation. The patient symptoms resolved approximately 1 month later. Attempts have been made and no further information has been provided.

  Patient problems: Pain; Tendinopathy

  MAUDE report 50310410 ↗
• MalfunctionJun 11, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE (1) YEAR AND THREE (3) MONTHS POST-IMPLANTATION, IT WAS REPORTED THAT AN INCORRECTLY SIZED ARTICULAR SURFACE HAD BEEN IMPLANTED. NO ABNORMALITIES OR COMPLICATIONS HAVE BEEN REPORTED AND THE PRODUCT REMAINS IMPLANTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509517 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY AND ONE DAY POST-OP EXPERIENCED A SIGNIFICANT AMOUNT OF DRAINAGE. TWO ADDITIONAL SUTURES WERE PLACED TO THE DISTAL PORTION OF THE INCISION. EIGHT DAYS LATER, THE PATIENT WAS SEEN IN THE OFFICE FOR A FOLLOW-UP APPOINTMENT AND THE DOCTOR NOTES HE COULD SEE WHERE HE HAD SOME BLOODY DRAINAGE AT THE DISTAL PORTION OF THE INCISION. DERMABOND WAS PLACED ON THE DISTAL INCISION AND THE PATIENT WAS PLACED IN A KNEE IMMOBILIZER FOR THE WEEKEND AND PRESCRIBED PROPHYLACTIC ANTIBIOTICS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT FURTHER WOUND COMPLICATIONS.

  Patient problems: Fluid Discharge

  MAUDE report 19315353 ↗