PERSONA® Vivacit-E® 42-5221-004-11 (UDI 00889024468108)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024468108), received between Nov 2, 2021 and Nov 4, 2025 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE TO ADDRESS INFECTION ACCOMPANIED BY PAIN AND SWELLING APPROXIMATELY ONE (1) MONTH POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23462760 ↗
• MalfunctionJun 18, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT WHEN THE SURGEON WENT TO INSERT THE MC POLY INTO THE FINAL TIBIA, IT WOULDN¿T SEAT DOWN. THE SURGEON NOTICED THAT THE POLY LOOKED DAMAGED ON THE MEDIAL RIDGE, HOWEVER, THEY WERE NOT SURE IF THAT WAS DAMAGED OUT OF THE PACKAGE OR NOT. ANOTHER POLY WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286161 ↗
• InjuryMar 25, 2025Adverse 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: Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 21687690 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION FIFTEEN (15) DAYS POST-OPERATIVELY TO ADDRESS INFECTION. ONLY THE ARTICULAR SURFACE WAS REPLACED. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 20455645 ↗
• InjuryJun 12, 2024Adverse 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: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain

  MAUDE report 19522093 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. A FEW DAYS FOLLOWING THE SURGERY, WHILE THE PATIENT WAS STILL IN THE HOSPITAL, THEY MIS-STEPPED AND TORE MULTIPLE LIGAMENTS. PATIENT WAS REVISED A WEEK POST-IMPLANTATION DUE TO LIGAMENT AND SOFT TISSUE DAMAGE.

  Patient problems: Damage to Ligament(s)

  MAUDE report 19323084 ↗
• InjuryOct 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTS LIMITED FLEXION AFTER FIFTEEN MONTHS OF PHYSICAL THERAPY. NO REVISION PROCEDURE HAS BEEN REPORTED.

  Patient problems: Insufficient Information; Loss of Range of Motion

  MAUDE report 15684495 ↗
• MalfunctionJul 27, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED POST IMPLANTATION THAT THE WRONG SIDE IMPLANTS WERE IMPLANTED. THE SURGEON WILL MONITOR THE PATIENT THROUGH THE REHABILITATION PROCESS. NO REVISION HAS BEEN PLANNED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15112021 ↗
• InjuryMar 10, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY AND WAS SUBSEQUENTLY REVISED APPROXIMATELY 15 MONTHS LATER DUE TO AN INJURY WITH PCL RUPTURE WITH FLEXION INSTABILITY. DURING THE REVISION, THE COMPONENTS WERE WELL FIXED WITH LAXITY IN FLEXION. THE FEMUR, STEM, AND POLYETHYLENE WERE EXCHANGED WITHOUT COMPLICATIONS. THE TIBIA AND PATELLA REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity; Loss of Range of Motion; Muscle/Tendon Damage; Pain

  MAUDE report 13720923 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REPORTED EXPERIENCING PAIN AND INFLAMMATION IN THE KNEE APPROXIMATELY ONE YEAR POST-IMPLANTATION. A STEROID INJECTION WAS GIVEN IN THE KNEE DUE TO IMPINGEMENT OF THE FEMORAL IMPLANT ON THE IT BAND DUE TO OVERHANG. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Pain

  MAUDE report 12738485 ↗