PERSONA® Vivacit-E® 42-5121-004-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024468979), received between Dec 6, 2021 and Aug 4, 2026 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient underwent a revision approximately 2 years and 8 months post-implantation due to flexion instability. It was reported that no further information is available.

  Patient problems: Joint Laxity

  MAUDE report 50133122 ↗
• InjuryOct 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN AND GRINDING IN THE KNEE AFTER A FALL. DURING THE REVISION, THE POSTERIOR LATERAL ASPECT OF THE POLYETHYLENE ARTICULAR SURFACE WAS FRACTURED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 23369172 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION DUE TO INSTABILITY ONE YEAR SIX MONTHS POST IMPLANTATION. EXCHANGED FROM MC TO UC POLY, AND FROM 10MM TO 12MM.

  Patient problems: Joint Laxity

  MAUDE report 20843496 ↗
• MalfunctionNov 5, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE WOULD NOT ENGAGE PROPERLY WITH THE TIBIAL TRAY. AFTER VERIFYING THERE WAS NO SOFT TISSUE INTERFERENCE PREVENTING THE ARTICULAR SURFACE FROM SEATING, THE SURGEON OPTED TO USE A DUPLICATE DEVICE. THE SECOND BEARING WAS SEATED WITHOUT DIFFICULTY. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612380 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY TWELVE MONTHS POST-IMPLANTATION DUE TO NERVE DAMAGE RESULTING IN AN ALTERED GAIT AND LEADING TO THE PATIENT BEING LOOSE IN FLEXION. THE ARTICULAR SURFACE WAS REMOVED AND REPLACED.

  Patient problems: Ambulation or Postural Difficulties; Nerve Damage

  MAUDE report 19259845 ↗
• MalfunctionJun 26, 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 17199836 ↗
• MalfunctionJun 23, 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 17190099 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ONE YEAR POST IMPLANTATION DUE TO PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Fall; Pain

  MAUDE report 15426503 ↗
• MalfunctionSep 7, 2022Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT A SURGEON WAS UNABLE TO INSERT THE ARTICULAR SURFACE TO THE TIBIA PLATE BECAUSE THE DOVE TAIL DEFORMED. SUBSEQUENTLY, ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15372793 ↗
• MalfunctionDec 6, 2021Difficult 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 12939740 ↗