PERSONA® Vivacit-E® 42-5221-008-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00889024468412), received between Mar 23, 2021 and Aug 3, 2026 — classified as 30 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (6 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122472 ↗
• MalfunctionAug 3, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122467 ↗
• MalfunctionMay 21, 2026Difficult to Insert

  IT WAS REPORTED THAT INTRAOPERATIVELY THE ARTICULAR SURFACE COULD NOT BE LOCKED INTO THE TIBIAL COMPONENT. THE SURGICAL TECHNIQUE WAS UTILIZED; THERE WAS NO SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247676 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, 12 DAYS POST IMPLANTATION THE PATIENT PRESENTED WITH SEROUS DRAINAGE FROM THE DISTAL INCISION AND WAS PRESCRIBED AUGMENTIN. THE INCISION WAS HEALED AT THE NEXT FOLLOW-UP A MONTH LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fluid Discharge

  MAUDE report 23854519 ↗
• InjuryDec 10, 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: Insufficient Information

  MAUDE report 23768192 ↗
• InjurySep 17, 2025Adverse 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 KNEE SURGERY. APPROXIMATELY 3 YEARS POST-OP, THE PATIENT IS STILL EXPERIENCING PAIN. IMAGING DID NOT REVEAL ANY ISSUES WITH THE IMPLANT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Synovitis

  MAUDE report 23072658 ↗
• InjuryAug 26, 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 RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO (2) YEARS AND TWO (2) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN. THE TIBIAL TRAY AND ARTICULAR SURFACE WERE REPLACED WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 22893400 ↗
• InjuryAug 12, 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 FOUR (4) WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A DEBRIDEMENT AND ARTICULAR SURFACE EXCHANGE DUE TO INFECTION. IT WAS ALSO NOTED THAT THE PATIENT HAD A KNOWN FALL ONE (1) WEEK POST-IMPLANTATION AND THE SURGEON UPSIZED THE BEARING AS THE KNEE WAS A LITTLE LOOSE IN FLEXION. IT WAS REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 22784883 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A KNEE REVISION PROCEDURE SIX MONTHS POST PROCEDURE DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 22748731 ↗
• InjuryJun 23, 2025Adverse 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 1 YEAR POST-OP, THE PATIENT DEVELOPED PAIN AND EFFUSION. SIX ASPIRATIONS HAVE BEEN PERFORMED WITH THE LATEST RESULTING IN 600 WBC AND THE PATIENT WAS DIAGNOSED WITH SYNOVITIS. X-RAY SHOWED FEMORAL COMPONENT LOOSENING ALONG WITH COMPLAINTS OF AMBULATION DIFFICULTIES AND JOINT LAXITY. REVISION WAS RECOMMENDED BY SURGEON. NO FURTHER INFORMATION PROVIDED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Joint Laxity; Joint effusion; Loss of Range of Motion; Pain; Synovitis

  MAUDE report 22307393 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND DIFFICULTY AMBULATING APPROXIMATELY TWENTY-ONE (21) MONTHS FOLLOWING RIGHT KNEE ARTHROPLASTY. A REVISION SURGERY TO REMOVE THE ARTICULAR SURFACE IS BEING DISCUSSED, HOWEVER, NO MEDICAL INTERVENTION HAS BEEN REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 22151274 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION DUE TO INFECTION APPROXIMATELY TWO (2) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22063097 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE TO ADDRESS LIGAMENT LAXITY INSTABILITY AND EDEMA APPROXIMATELY FIVE (5) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Swelling/ Edema

  MAUDE report 21967739 ↗
• InjuryMar 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  T WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE AND PATELLAR COMPONENTS APPROXIMATELY TWO (2) YEARS POST-OPERATIVELY DUE TO LOOSENING. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21706686 ↗
• InjuryMar 17, 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: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 21620689 ↗
• InjuryFeb 18, 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: Loss of Range of Motion

  MAUDE report 21397083 ↗
• MalfunctionJan 17, 2025Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178457 ↗
• MalfunctionJan 14, 2025Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT WHILE THE SURGEON WAS ATTEMPTING TO SEAT THE ARTICULAR SURFACE IMPLANT, THE DEVICE COULD NOT BE INSERTED ON THE TIBIAL TRAY. UPON EXAMINATION OF THE IMPLANT, IT APPEARED TO BE WARPED AROUND THE LOCKING MECHANISM. ANOTHER ARTICULAR SURFACE 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 21149656 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY ONE YEAR POST-OP, THE PATIENT WAS REVISED DUE TO STIFFNESS AND PATELLA PAIN AFTER A FALL. THE POLY WAS EXCHANGED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Loss of Range of Motion; Pain

  MAUDE report 20358916 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY TWO (2) YEARS POST-IMPLANTATION AS THEY WERE UNHAPPY AND HAD A STIFF KNEE. IT WAS ALSO NOTED THE PATIENT SUSTAINED A FALL, BUT IT IS UNKNOWN IF THE STIFFNESS CAUSED THE FALL, OR WAS A RESULTING SYMPTOM AFTER THE FALL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 20143726 ↗
• MalfunctionAug 20, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT WHEN THE ARTICULAR SURFACE IMPLANT WAS OPENED, THE OUTER STERILE PLASTIC CARTON WAS DEFORMED AND THE INNER STERILE PAPER COVER WAS IDENTIFIED TO NOT BE SEALED COMPLETELY TO THE CARTON. THE OUTER PACKAGING EXHIBITED NO ISSUES AND WAS PROPERLY SEALED. 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 20004892 ↗
• InjuryAug 14, 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: Damage to Ligament(s)

  MAUDE report 19986559 ↗
• MalfunctionAug 13, 2024Off-Label Use; Off-Label Use

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973173 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ONE MONTHS POST IMPLANTATION DUE TO INSTABILITY. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19659038 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TEN MONTHS POST IMPLANTATION DUE TO PAIN, SWELLING, PERIPROSTHETIC FRACTURE, IMPLANT LOOSENING, AND INFECTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Joint Contracture; Osteolysis; Osteopenia/ Osteoporosis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19166637 ↗