PERSONA® Vivacit-E® 42-5121-009-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024469426), received between Apr 11, 2024 and Jul 24, 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.

• InjuryJul 24, 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: Fluid Discharge; Impaired Healing

  MAUDE report 19817357 ↗
• InjuryJul 24, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE WRONG PRODUCT WAS IMPLANTED INTO A PATIENT. THE PATIENT ACCIDENTALLY RECEIVED CEMENTLESS IMPLANTS INTRAOPERATIVELY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817156 ↗
• MalfunctionApr 11, 2024Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT WHEN THE ARTICULATING SURFACE WAS BEING IMPLANTED, IT WOULD NOT MATE WITH THE TIBIAL IMPLANT. UPON REMOVAL TO INSPECT, IT WAS NOTICED THAT THE BOTTOM OF THE IMPLANT WAS SLIGHTLY DAMAGED AROUND THE LOCKING MECHANISM. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087498 ↗