PERSONA® Vivacit-E® 42-5221-005-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024468177), received between Sep 30, 2019 and Nov 26, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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.

• MalfunctionNov 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658546 ↗
• InjuryJun 25, 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: Fall; Hyperextension; Wound Dehiscence

  MAUDE report 22326987 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY SIX (6) WEEKS POST-IMPLANTATION, THE PATIENT REQUIRED A MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS AND LIMITED FLEXION FROM NOT COMPLETING THE PRESCRIBED POSTOP THERAPY. THE PATIENT OUTCOME IS REPORTED AS IMPROVING.

  Patient problems: Loss of Range of Motion

  MAUDE report 19567066 ↗
• InjuryJun 1, 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: Muscular Rigidity

  MAUDE report 17040278 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY ELEVEN MONTHS POST IMPLANTATION DUE TO STIFFNESS AND ARTHROFIBROSIS.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 15164183 ↗
• MalfunctionApr 20, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT. THE HOSPITAL IMPLANTED A WRONG SIZE INSERT, ONE THAT IS MEANT TO BE USED WITH A BIGGER FEMUR. THIS WAS DISCOVERED AFTER SURGERY. THE PATIENT WAS NOTED TO BE IN GOOD AND STABLE MOTION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14161499 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT KNEE ARTHROPLASTY AND WAS NOTED TO HAVE STIFFNESS AND DECREASED RANGE OF MOTION DURING THEIR ONE MONTH FOLLOW-UP VISIT. PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO WEEKS LATER AND AGAIN APPROXIMATELY ONE MONTH LATER. PATIENT CONTINUES TO HAVE PAIN AND STIFFNESS AS OF THE THREE MONTH FOLLOW UP.

  Patient problems: Loss of Range of Motion

  MAUDE report 9134990 ↗