PERSONA® Vivacit-E® 42-5121-004-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024469006), received between Mar 21, 2023 and Oct 25, 2024 — classified as 2 injuries, 1 malfunction.

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

• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DRAINAGE FROM THE INCISION APPROXIMATELY THREE (3) MONTHS FOLLOWING A LEFT KNEE ARTHROPLASTY. THE PATIENT WAS INSTRUCTED TO APPLY ANTIBIOTIC OINTMENT, KEEP THE INCISION COVERED AND WAS PRESCRIBED AN ANTIBIOTIC PROPHYLACTICALLY. THE PATIENT'S DRAINAGE WAS REPORTEDLY RESOLVED SEVEN (7) MONTHS LATER. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Impaired Healing

  MAUDE report 20533933 ↗
• MalfunctionApr 4, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, THE TIBIAL INSERT WOULD NOT SEAT ON THE TIBIAL TRAY. THE PROCEDURE WAS COMPLETED USING ANOTHER TIBIAL INSERT THAT WAS ON HAND. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16673540 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN, SWELLING, DAMAGED NERVE AND RANGE OF MOTION POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Nerve Damage; Pain; Swelling/ Edema

  MAUDE report 16585777 ↗