PERSONA® Vivacit-E® 42-5121-007-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024469228), received between Mar 10, 2022 and Feb 2, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE SURGERY. APPROXIMATELY 3.5 YEARS POSTOP, THE PATIENT WAS REVISED DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 24232919 ↗
• MalfunctionJan 27, 2026Positioning Failure

  IT WAS REPORTED THAT THE SURGEON INSERTED POLY INSERT INTO THE TIBIAL TRAY AND DID NOT HEAR A CLICK SOUND. A BIG GAP WAS OBSERVED AND THE SURGEON TRIED TO REINSERT THE POLY, HOWEVER, THEY STILL DID NOT HEAR THE CLICK SOUND. THE SURGEON USED A DIFFERENT POLY AND THE SOUND WAS SUCCESSFULLY HEARD. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191040 ↗
• InjuryNov 3, 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: Cellulitis; Confusion/ Disorientation; Fever; Medical device site infection; Pain; Swelling/ Edema

  MAUDE report 23452841 ↗
• MalfunctionOct 10, 2024Difficult 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 20417941 ↗
• MalfunctionMay 30, 2023Difficult 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 17021929 ↗
• MalfunctionDec 6, 2022Difficult 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 15921927 ↗
• InjuryMay 19, 2022Unstable; Unstable

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY, LOWERED JOINT LINE, AND POOR PATELLA TRACKING.

  Patient problems: Failure of Implant

  MAUDE report 14435898 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY EIGHT MONTHS POST-IMPLANTATION DUE TO ARTHROFIBROSIS AND IMPLANT MALPOSITION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE

  Patient problems: Adhesion(s); Scar Tissue

  MAUDE report 13721133 ↗