PERSONA® Vivacit-E® 42-5121-009-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00889024469372), received between Oct 13, 2020 and Mar 16, 2026 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Arthrofibrosis; Loss of Range of Motion

  MAUDE report 24607951 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 24382566 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT REPORTED EXPERIENCING STIFFNESS AND UNDERWENT AN ARTHROSCOPY WHERE NO DEVICES WERE EXCHANGED AND THE PATIENT SUBSEQUENTLY DEVELOPED AN INFECTION. THE PATIENT WAS THEN REVISED DUE TO INFECTION. A WASHOUT WAS PERFORMED AND THE POLY WAS EXCHANGED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Medical device site infection

  MAUDE report 24380063 ↗
• MalfunctionJan 26, 2026Difficult to Insert

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE ARTICULAR SURFACE COULD NOT BE SUCCESSFULLY SEATED ONTO THE TIBIAL TRAY. A NEW ARTICULAR SURFACE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS OCCURRED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179420 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity; Pain

  MAUDE report 23988206 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity; Pain

  MAUDE report 23897238 ↗
• 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 LEFT TOTAL KNEE ARTHROPLASTY. TWO (2) MONTHS POST-IMPLANTATION, THE PATIENT REPORTED EXPERIENCED A FALL WHICH LED TO INCREASED PAIN, DECREASED RANGE OF MOTION AND TROUBLE BEARING WEIGHT. TWO (2) MONTHS FOLLOWING THE FALL, THE PAIN CONTINUED WITH THE FEELING OF THE KNEE MOVING AND LOCKING UP. A KNEE ASPIRATION WAS PERFORMED THAT WAS NEGATIVE. A SECOND KNEE ASPIRATION DONE TWO WEEKS LATER THAT WAS ALSO NEGATIVE AND A CORTISONE INJECTION WAS GIVEN. FIVE (5) MONTHS POST-FALL, THE PATIENT OUTCOME IS PENDING AS THE PAIN, SWELLING, CREPITUS AND RANGE OF MOTION AND WEIGHT BEARING ISSUES CONTINUE REGARDLESS OF INTERVENTION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Crepitus; Joint Laxity; Joint locking; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 22898037 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A BEARING REPLACEMENT REVISION SURGERY DUE TO AN UNSPECIFIED INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE FROM THE HCP.

  Patient problems: Unspecified Infection

  MAUDE report 22874294 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 22779639 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Joint Laxity

  MAUDE report 22779637 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information; Pain; Unspecified Infection

  MAUDE report 22663139 ↗
• InjuryFeb 4, 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: Scar Tissue

  MAUDE report 21306925 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA TO ADDRESS STIFFNESS, LIMITED RANGE OF MOTION, AND PAIN APPROXIMATELY THREE (3) MONTHS FOLLOWING KNEE ARTHROPLASTY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS AND THE PATIENT WAS IN STABLE CONDITION UPON COMPLETION OF THE PROCEDURE. MANIPULATION OPERATIVE NOTES NOTE THE PATIENT ACHIEVED 5-120 DEGREES OF RANGE OF MOTION WITH NO INTRAOPERATIVE COMPLICATIONS. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 21263725 ↗
• InjuryDec 13, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 20925525 ↗
• InjuryNov 11, 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

  MAUDE report 20653673 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION FOR PATIENT PAIN. THE FEMUR, TIBIA, PATELLA AND POLY WERE REMOVED AND NEW REVISION PRODUCTS IMPLANTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Pain

  MAUDE report 18467630 ↗
• InjuryNov 15, 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 1.5 YEARS POST IMPLANTATION DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 18144588 ↗
• InjuryAug 10, 2022Unstable; Noise, Audible; Unstable; Noise, Audible

  IT WAS REPORTED THE PATIENT IS REPORTING PAIN, SWELLING, INSTABILITY, AND AN AUDIBLE CLICKING NOISE APPROXIMATELY 4 YEARS POST IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. HOWEVER; NO MORE IS AVAILABLE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15197965 ↗
• InjuryAug 31, 2021Adverse 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 12396641 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 12168141 ↗
• InjuryJul 14, 2021Adverse 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: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 12168085 ↗
• MalfunctionOct 13, 2020Device 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 Patient Involvement

  MAUDE report 10670047 ↗