PERSONA® Vivacit-E® 42-5121-007-10 (UDI 00889024469211)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00889024469211), received between Nov 2, 2020 and Dec 15, 2025 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Laxity

  MAUDE report 23810355 ↗
• MalfunctionSep 11, 2025Positioning Failure; Positioning Failure

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025491 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE SURGERY. APPROXIMATELY 13 MONTHS POST-OP, THE PATIENT REPORTED THAT THEIR KNEE FELT LOOSE AND THE SURGEON SUSPECTED THAT THE POLY WAS NOT THICK ENOUGH. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INSTABILITY. THE POLY WAS REVISED AND INCREASED TO A LARGER THICKNESS. THERE WERE NO SIGNS OF POLY WEAR. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 22357035 ↗
• MalfunctionJun 11, 2025Positioning Failure; Material Twisted/Bent; Positioning Failure; Material Twisted/Bent

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187989 ↗
• InjuryMay 30, 2025Naturally Worn; Naturally Worn

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Failure of Implant

  MAUDE report 22113705 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 56 DAYS POST IMPLANTATION, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO DECREASED RANGE OF MOTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion

  MAUDE report 21060802 ↗
• InjuryJun 27, 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: Loss of Range of Motion; Pain

  MAUDE report 19628786 ↗
• MalfunctionMay 9, 2024Positioning Failure; Positioning Failure

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281110 ↗
• InjuryApr 22, 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: Pain

  MAUDE report 19155495 ↗
• MalfunctionOct 5, 2022Packaging Problem; Packaging Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544712 ↗
• InjuryMay 10, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT A PATIENT EXPERIENCED LEFT KNEE PAIN AND CLICKING THAT REQUIRED MEDICAL INTERVENTION APPROXIMATELY TEN MONTHS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 14349329 ↗
• MalfunctionOct 14, 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 12636593 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO MONTHS AND ONE-WEEK POST IMPLANTATION DUE TO ARTHROFIBROSIS. THE PATIENT COMPLETED THE STUDY SATISFIED APPROXIMATELY ONE YEAR AND FIVE MONTHS LATER WITHOUT FURTHER COMPLICATIONS REQUIRING INTERVENTION. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 11495882 ↗
• InjuryNov 2, 2020Difficult to Insert; Off-Label Use; Difficult to Insert; Off-Label Use

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10770192 ↗