PERSONA® Vivacit-E® 42-5221-008-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024468443), received between Aug 21, 2020 and Mar 5, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 8 WEEKS POST-OP, THE PATIENT HAD A FLEXION CONTRACTURE WITH A RANGE OF MOTION OF 13 - 106 DEGREES AND DEVELOPED ARTHROFIBROSIS. SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA. POSTOPERATIVELY, FULL EXTENSION WAS ACHIEVED AND FLEXION EXCEED 130 DEGREES WITH NO COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ankylosis; Loss of Range of Motion; Scar Tissue

  MAUDE report 24518047 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY SIXTEEN (16) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY TO SWAP THE ARTICULAR SURFACE DUE TO STIFFNESS OF THE IMPLANTED JOINT. THE BEARING WAS EXCHANGED WITH NO REPORTED COMPLICATION. IT WAS REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion

  MAUDE report 22188220 ↗
• InjuryMay 14, 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: Aseptic loosening

  MAUDE report 22021237 ↗
• MalfunctionJun 11, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE (1) YEAR AND EIGHT (8) MONTHS POST-IMPLANTATION, IT WAS REPORTED THAT AN INCORRECTLY SIZED ARTICULAR SURFACE HAD BEEN IMPLANTED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION OR MEDICAL INTERVENTION HAS BEEN REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509614 ↗
• MalfunctionMar 14, 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 16538367 ↗
• MalfunctionJul 20, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY, THE ARTICULAR SURFACE COULD NOT BE IMPLANTED AFTER NUMEROUS ATTEMPTS. THE DEVICE WAS DEEMED TOO DEFORMED TO IMPLANT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070318 ↗
• MalfunctionFeb 18, 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 11343117 ↗
• InjurySep 18, 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: Impaired Healing; Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 10552880 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS NOTED TO HAVE AN ACUTE PULMONARY EMBOLISM ON THREE DAYS POST-OP, FOLLOWING A PRIMARY RIGHT UNILATERAL TOTAL KNEE, REQUIRING HOSPITALIZATION AND MEDICAL INTERVENTION.

  Patient problems: Embolism; Patient Problem/Medical Problem

  MAUDE report 10436957 ↗