PERSONA® Vivacit-E® 42-5121-008-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024469327), received between Jun 7, 2021 and Oct 15, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A HAIR WAS FOUND INSIDE THE IMPLANT PACKAGING. NO PATIENT HARM OR IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292029 ↗
• MalfunctionMay 28, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096453 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. ONE WEEK POST IMPLANTATION, THE PATIENT DEVELOPED WOUND DRAINAGE COMPLICATIONS REQUIRING APPLICATION OF A KNEE IMMOBILIZER. TWO MONTHS POST IMPLANTATION THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS AND LIMITED FLEXION. THE PATIENT CONTINUED TO REPORT STIFFNESS AND WAS PLACED IN A SPLINT. ONE MONTH AFTER THE MANIPULATION UNDER ANESTHESIA, THE PATIENT UNDERWENT AN OPEN RESECTION FOR SCAR TISSUE DUE TO ARTHROFIBROSIS. THE PATIENT WAS ULTIMATELY REVISED APPROXIMATELY TEN MONTHS POST IMPLANTATION DUE TO ONGOING PAIN, DIFFICULTY AMBULATING, AND ARTHROFIBROSIS. DURING THE REVISION, EXTENSIVE SCAR TISSUE WAS NOTED AS WELL AS A PSEUDO MENISCUS FORMATION CIRCUMFERENTIALLY AROUND THE JOINT. THE FEMORAL COMPONENT AND ARTICULAR SURFACE WERE EXCHANGED AND THE PATELLA WAS RESURFACED WITHOUT COMPLICATION. THE TIBIAL COMPONENT REMAINS IMPLANTED.

  Patient problems: Impaired Healing; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 12576553 ↗
• InjuryJun 29, 2021Use of Device Problem; Use of Device Problem

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

  Patient problems: Insufficient Information

  MAUDE report 12086031 ↗
• MalfunctionJun 7, 2021Device 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 11947919 ↗