PERSONA® Vivacit-E® 42-5121-004-12 (UDI 00889024468993)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024468993), received between Jul 6, 2021 and Apr 22, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 6 MONTHS BEFORE, THE PATIENT REPORTED EXPERIENCING A POPPING SENSATION. ON EVALUATION, THE PATIENT DEMONSTRATED GOOD STABILITY, BALANCE, AND APPROPRIATE PATELLAR TRACKING. THE PATIENT WAS DIAGNOSED WITH PATELLAR TENDINITIS, PES ANSERINE BURSITIS, AND ILIOTIBIAL BAND INSERTIONAL TENDERNESS. TREATMENT INCLUDED A LEFT BURSA INJECTION AND A LEFT ILIOTIBIAL BAND INJECTION. THE PATIENT WAS ALSO INSTRUCTED TO APPLY A TOPICAL ANTI-INFLAMMATORY CREAM AND WAS PROVIDED WITH A COMPRESSION STOCKING. THERE WERE NO CONCERNS OR ALLEGATIONS REGARDING THE IMPLANTED COMPONENTS, WHICH REMAIN IN PLACE. THE EVENT HAS BEEN REPORTED AS RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Discomfort; Tendinopathy

  MAUDE report 24955038 ↗
• MalfunctionMar 12, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO INSERT THE ARTICULAR SURFACE MULTIPLE TIMES, HOWEVER, IT WOULD NOT GO IN. ANOTHER ARTICULAR SURFACE MATED WITH THE SAME TIBIAL PLATE WITHOUT PROBLEM AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THERE WAS A LESS THAN 30 MINUTE SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586877 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS ACCOMPANIED BY STIFFNESS, LIMITED RANGE OF MOTION AND A 1-5 DEGREE FLEXION CONTRACTURE APPROXIMATELY THREE (3) MONTHS FOLLOWING LEFT KNEE ARTHROPLASTY. THE PATIENT WAS REPORTEDLY IMPROVING FOLLOWING THE MANIPULATION. REPORTEDLY, NO INTRAOPERATIVE COMPLICATIONS WERE NOTED DURING THE INITIAL PROCEDURE.

  Patient problems: Adhesion(s); Joint Contracture; Loss of Range of Motion; Scar Tissue

  MAUDE report 20363413 ↗
• InjurySep 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE MANIPULATION UNDER ANESTHESIA APPROXIMATELY FORTY DAYS POST-IMPLANTATION DUE TO ARTHROFIBROSIS, STIFFNESS, AND LIMITED FLEXION. IT WAS REPORTEDLY RESOLVED THE SAME DAY AND ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 15465059 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA STUDY THAT THE PATIENT DEVELOPED A PULMONARY EMBOLISM REQUIRING HOSPITALIZATION APPROXIMATELY FORTY (40) DAYS POST IMPLANTATION. NO FURTHER INTERVENTIONS HAVE BEEN REPORTED.

  Patient problems: Pulmonary Embolism

  MAUDE report 15244618 ↗
• InjuryJul 26, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO INSTABILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 15104971 ↗
• MalfunctionJul 6, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE TIBIAL INSERT WOULD NOT SEAT IN THE TIBIAL TRAY. A SECOND TIBIAL INSERT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12121491 ↗