PERSONA® Vivacit-E® 42-5121-008-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00889024469297), received between Feb 26, 2020 and Jul 27, 2026 — classified as 27 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50036117 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 3.5 YEARS POST-OP, THE PATIENT WAS EXPERIENCING PAIN WITHOUT RELIEF FROM PHYSIOTHERAPY, A PAIN MANAGEMENT SPECIALIST, AND REHABILITATION. IMAGING REVEALED INCREASED UPTAKE AT THE PATELLA AND MEDIAL TIBIAL AREA. SUBSEQUENTLY, THE PATIENT WAS REVISED. ALL COMPONENTS WERE REVISED. THERE WAS NO LOOSENING SEEN, HOWEVER, THE SURGEON NOTED AREAS OF SOFTER BONE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 24052747 ↗
• InjuryDec 29, 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: Joint Laxity

  MAUDE report 23915408 ↗
• InjuryNov 17, 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: Damage to Ligament(s); Joint Laxity

  MAUDE report 23567827 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A JOURNAL ARTICLE WAS RETRIEVED FROM KNEE SURGERY, SPORTS TRAUMATOLOGY, ARTHROSCOPY THAT REPORTED A STUDY FROM DENMARK. THE STUDY REPORTED ONE PATIENT FROM THE MC GROUP HAD A TKA REVISION SURGERY TO A KNEE WITH TIBIA STEM LENGTHENING AT 24 MONTHS FOLLOW-UP DUE TO PAIN AND RESTRICTED ROM IN BOTH FLEXION AND EXTENSION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 23434675 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A STUDY THAT APPROXIMATELY 1 MONTH POST IMPLANTATION OF A LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS DIAGNOSED WITH CELLULITIS AND WAS PRESCRIBED ANTIBIOTICS, AS WELL AS UNDERWENT A WOUND DEBRIDEMENT, IRRIGATION, AND WOUND CARE. THE PATIENT WAS REPORTED AS FULLY HEALED APPROXIMATELY 6 WEEKS LATER. DEVICES REMAIN IMPLANTED. ATTEMPTS WERE MADE AND ALL AVAILABLE INFORMATION WAS PROVIDED.

  Patient problems: Cellulitis

  MAUDE report 22668498 ↗
• InjuryJun 23, 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: Joint effusion; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 22306633 ↗
• InjuryMay 1, 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 21941670 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information

  MAUDE report 21756143 ↗
• InjuryNov 12, 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 LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, 7 DAYS POST IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE CHEST TIGHTNESS. THE PATIENT WAS ULTIMATELY DIAGNOSED WITH MYOCARDIAL INFARCTION REQUIRING PLACEMENT OF 2 STENTS APPROXIMATELY 15 DAYS POST IMPLANTATION. THE EVENT HAS NOW BEEN DOCUMENTED WITHIN THE STUDY AS RESOLVED, NO DEVICE DEFICIENCIES OR ABNORMALITIES HAVE BEEN REPORTED AT THE 3-MONTH FOLLOW-UP AND ALL INITIAL COMPONENTS REMAIN IMPLANTED.

  Patient problems: Myocardial Infarction

  MAUDE report 20664908 ↗
• InjuryOct 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 20545480 ↗
• InjuryOct 16, 2024Naturally Worn; Naturally Worn

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 20463983 ↗
• InjurySep 27, 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: Loss of Range of Motion; Scar Tissue

  MAUDE report 20320955 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY THREE MONTHS POST IMPLANTATION DUE TO STIFFNESS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 20127808 ↗
• InjuryAug 22, 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: Insufficient Information

  MAUDE report 20030082 ↗
• InjuryAug 22, 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: Insufficient Information

  MAUDE report 20023924 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR THREE WEEKS POST IMPLANTATION DUE TO PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 19208390 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY TWO MONTHS POST-IMPLANTATION DUE TO INFECTION. THE TIBIAL INSERT WAS REMOVED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 18400746 ↗
• InjuryDec 21, 2023Unstable; Unstable

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Insufficient Information

  MAUDE report 18379303 ↗
• MalfunctionOct 30, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE TIBIAL INSERT WOULD NOT SEAT ON THE TIBIAL TRAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER TIBIAL INSERT THAT WAS AVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18034851 ↗
• InjuryOct 9, 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: Loss of Range of Motion; Pain

  MAUDE report 17900473 ↗
• InjurySep 28, 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: Loss of Range of Motion; Pain

  MAUDE report 17832785 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. AT 3 MONTHS POST OP, THE PATIENT WAS PAIN FREE WITH 120 DEGREES FLEXION. APPROXIMATELY 4 MONTHS POST IMPLANTATION, THE PATIENT PRESENTED WITH KNEE PAIN. THE ORIGINAL REASON FOR REVISION WAS FOR SUSPECTED INFECTION, HOWEVER, THE SURGEON MENTIONED THE KNEE DID NOT LOOK INFECTED WHEN REMOVING THE PROSTHESIS. THE SURGEON TOOK 6 SWABS, 3 ON DISTAL FEMUR AND 3 ON PROXIMAL TIBIA. WHEN REMOVING THE TIBIA, IT WAS NOTED THAT THE MEDIAL TM PEG HAD SNAPPED PRIOR TO ATTEMPTS TO REMOVE. THE BONE INGROWTH ON THE UNDERSIDE OF TM TIBIA WAS SMALL. THE PEG THAT WAS LEFT IN PATIENT HAD BONE INGROWTH. IT WAS NOTED THAT THE MEDIAL TM PEG IS NOT PERPENDICULAR TO THE BASEPLATE IN X-RAYS. ADDITIONALLY, METAL DEBRIS SEEN IN X-RAYS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 16860491 ↗
• MalfunctionApr 25, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY WOULDN¿T LOCK IN. STAFF OPENED A NEW POLY AND IT LOCKED IN. 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 16806706 ↗
• InjuryMar 16, 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: Bacterial Infection; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16553267 ↗