PERSONA® Vivacit-E® 42-5221-007-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024468337), received between Oct 16, 2019 and Sep 29, 2026 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Insert

  It was reported that during a knee arthroplasty an articular surface would not seat into the tibial baseplate despite multiple attempts. Attempts have been made, and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935109 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient underwent an initial right total knee arthroplasty. Subsequently, approximately five months post-implantation, the patient received a bupivacaine injection for pes anserinus bursitis and iliotibial band tendonitis. The patient experienced resolution of symptoms and reported being satisfied with the outcome. Attempts have been made and no further information has been provided.

  Patient problems: Bursitis; Tendinopathy

  MAUDE report 50017538 ↗
• MalfunctionDec 30, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT AN ARTICULAR SURFACE WOULD NOT ASSEMBLE WITH THE TIBIAL TRAY. THE LENS HAD DEFORMATION ON THE RAIL SECTION ON THE BACK SIDE OF THE SURFACE, PREVENTING PROPER INSERTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923039 ↗
• MalfunctionDec 4, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN STAFF OPENED THE POLY INSERT THEY FOUND IT HAD BLACK SPECS OF UNKNOWN SUBSTANCE ON IT. THE DEBRIS COULD BE BRUSHED OFF OF THE DEVICE. THE DEVICE WAS DISCARDED AND ANOTHER DEVICE WAS USED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847314 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO PAIN AND INSTABILITY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20517399 ↗
• InjurySep 25, 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: Unspecified Infection

  MAUDE report 20301052 ↗
• MalfunctionMay 14, 2024Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE BEARING WOULD NOT LOCK INTO THE TIBIA. THERE WAS A VISIBLE GAP AT THE ANTERIOR PORTION OF THE TIBIA BASE PLATE. A SECOND BEARING WAS USED WITH THE SAME RESULTS. THE SECOND BEARING COULD NOT BE REMOVED FROM THE TIBIA BASE PLATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310001 ↗
• MalfunctionOct 4, 2023Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT AT THE END OF THE CASE THE SURGEON ATTEMPTED TO INSERT THE POLYETHYLENE ARTICULAR SURFACE INTO THE TIBIAL IMPLANT AND HAD A PROBLEM GETTING THE DOVETAIL TO ENGAGE. UPON FURTHER INSPECTION, IT WAS DISCOVERED THAT IT LOOKED MISSHAPEN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868466 ↗
• InjurySep 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY HAD A MANIPULATION UNDER ANESTHESIA 4 MONTHS POST PROCEDURE DUE TO ARTHROFIBROSIS, STIFFNESS, AND DECREASED ROM.

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

  MAUDE report 15402417 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO DECREASED RANGE OF MOTION, ADHESIONS, AND SCAR TISSUE. THE ISSUE WAS RESOLVED.

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

  MAUDE report 14086755 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A RIGHT UNILATERAL TKA, AND THE PATIENT EXPERIENCED LYSIS OF ADHESIONS, LIMITED ROM, AND PAIN AND UNDERWENT A MUA APPROXIMATELY SIX MONTHS LATER.

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; Muscular Rigidity; Pain; Scar Tissue

  MAUDE report 10344433 ↗
• MalfunctionOct 16, 2019Difficult to Insert; Difficult to Insert

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9198022 ↗