PERSONA® Vivacit-E® 42-5221-008-12 (UDI 00889024468436)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00889024468436), received between Apr 10, 2020 and Sep 22, 2026 — classified as 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unstable” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a revision knee surgery due to instability approximately 7 months post-implantation with exchange of the polyethylene insert. Attempts have been made and no further information has been provided.

  Patient problems: Joint Laxity

  MAUDE report 50854090 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Discomfort

  MAUDE report 24544265 ↗
• InjuryDec 18, 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 23840326 ↗
• InjuryMar 27, 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: Ambulation or Postural Difficulties

  MAUDE report 21706684 ↗
• InjuryFeb 18, 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: Ambulation or Postural Difficulties

  MAUDE report 21401831 ↗
• InjuryJan 6, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FOUR YEARS POST IMPLANTATION DUE TO UNKNOWN REASON. GROSS TIBIA FAILURE AND PITTING WAS NOTICED ON THE ARTICULAR SURFACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 21079406 ↗
• InjuryDec 11, 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: Pain

  MAUDE report 20903182 ↗
• InjuryNov 19, 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: Cellulitis; Skin Discoloration

  MAUDE report 20723776 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED DEEP VEIN THROMBOSIS APPROXIMATELY SIX (6) DAYS FOLLOWING RIGHT KNEE ARTHROPLASTY AND REQUIRED ANTICOAGULATION THERAPY. REPORTEDLY, THE PATIENT HAS SINCE IMPROVED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED DURING THE INITIAL PROCEDURE. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19819166 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE EIGHTEEN DAYS POST IMPLANTATION DUE TO INFECTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 19752532 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information; Pain

  MAUDE report 19689417 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS EXPERIENCING PAIN AND STIFFNESS EIGHT MONTHS POST IMPLANTATION. ADDITIONAL PHYSICAL THERAPY AND RANGE OF MOTION MODALITIES WERE ORDERED. UPON COMPLETION OF THE STUDY AT ONE YEAR, ALL COMPONENTS REMAINED IN PLACE HOWEVER THE PATIENT REPORTEDLY UNDERWENT A PLANNED ARTHROSCOPY ON AN UNKNOWN DATE FOR POSSIBLE LYSIS OF ADHESIONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Joint effusion; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 19606449 ↗
• InjuryMay 8, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A REVISION APPROXIMATELY THREE (3) YEARS POST-IMPLANTATION DUE TO INSTABILITY AFTER THE PATIENT HAD A FALL WITH A LATERAL SOFT TISSUE INJURY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 19271891 ↗
• InjuryAug 30, 2023Adverse 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 PROCEDURE AND SUBSEQUENTLY WAS REVISED APPROXIMATELY 2.5 YEARS LATER DUE TO STIFFNESS. ONLY THE POLY WAS REVISED AND A PATELLAR IMPLANT WAS ALSO IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17653347 ↗
• InjuryAug 7, 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: Ambulation or Postural Difficulties; Pain

  MAUDE report 17469678 ↗
• InjuryJun 2, 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; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 17052458 ↗
• MalfunctionDec 17, 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 13024824 ↗
• MalfunctionMar 24, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY THE BEARING WOULD NOT SEAT DESPITE USING PROPER SURGICAL TECHNIQUE. ANOTHER BEARING OF THE SAME SIZE WAS OPENED AND INSERTED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11561052 ↗
• InjuryMay 7, 2020Adverse 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: Limited Mobility Of The Implanted Joint; Pain; Patient Problem/Medical Problem; Swelling

  MAUDE report 10032410 ↗
• InjuryApr 10, 2020Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 9948756 ↗