PERSONA® Vivacit-E® 42-5221-003-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024468023), received between Oct 14, 2021 and Jul 24, 2025 — classified as 7 injuries, 2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 2 YEARS AND 7 MONTHS POST IMPLANTATION DUE TO FALLING AND DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 22585463 ↗
• MalfunctionFeb 4, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE IMPLANT WAS NOT MATING WITH DEVICE AND WAS SLIPPING OUT. - ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305487 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 20695468 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT DEVELOPED A DEEP VEIN THROMBOSIS AND WAS TREATED WITH ELIQUIS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19166805 ↗
• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY AND PAIN. THE ARTICULATING SURFACE HEIGHT WAS INCREASED FROM 11MM TO 14MM AND CHANGED FROM AN MC INSERT TO A UC INSERT TO ADDRESS THE INSTABILITY. THE PATELLA WAS REVISED TO ADDRESS ANTERIOR KNEE PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19006595 ↗
• MalfunctionMar 14, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE TIBIAL INSERT WOULD NOT SEAT ON THE TIBIAL TRAY. THE PROCEDURE WAS COMPLETED WITH 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 16537694 ↗
• InjuryFeb 23, 2023Adverse 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: Pain

  MAUDE report 16428897 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS SIGNIFICANT INSTABILITY, DISCOMFORT, AND PAIN SECONDARY TO LATERAL LIGAMENT LAXITY IN FLEXION APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. THE PATIENT WAS REVISED TO A CONSTRAINING POST, WHICH RESTORED STABILITY AND CONFIRMED THE LATERAL LIGAMENT LAXITY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15672265 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED A DEEP VEIN THROMBOSIS ONE WEEK POSTOP. THE COMPLICATION RESOLVED TWO WEEKS LATER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12636283 ↗