PERSONA® Vivacit-E® 42-5121-008-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00889024469303), received between Oct 21, 2020 and Feb 13, 2026 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Positioning Failure

  IT WAS REPORTED POLY WOULD NOT ENGAGE PROPERLY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331756 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY (TKA). APPROXIMATELY ONE YEAR LATER, THE PATIENT REPORTED MILD PAIN AND STIFFNESS AND IS CURRENTLY RECEIVING PHYSICAL THERAPY. ALL COMPONENTS REMAIN IMPLANTED, AND THE EVENT IS RESOLVING.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 22972825 ↗
• MalfunctionMay 21, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE ARTICULAR SURFACE COULD NOT BE SEATED ON THE TIBIAL TRAY. ANOTHER ARTICULAR SURFACE WAS 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 22063516 ↗
• InjuryApr 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 BILATERAL KNEE ARTHROPLASTY. APPROXIMATELY 1 YEAR POST-OP, THE PATIENT UNDERWENT A BILATERAL KNEE REVISION DUE TO INSTABILITY. BOTH MC POLYS WERE REVISED AND THE THICKNESS WAS INCREASED. THE SURGEON NOTED THAT THEY THOUGHT THE PATIENT'S SOFT TISSUES HAD ''STRETCHED'' OVER TIME DUE TO EXCESSIVE TIBIA VARUS AND DID NOT THINK THE PROSTHESIS HAD ANY PART TO PLAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 21877162 ↗
• MalfunctionJan 22, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210174 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Adhesion(s); Fibrosis; Scar Tissue

  MAUDE report 19214924 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY. THE PATIENT HAD ARTHROFIBROSIS IN THE JOINT RESULTING IN DECREASED RANGE OF MOTION AND INCREASED SCARRING. SUBSEQUENTLY, THE PATIENT WAS REVISED TO REMOVE SCARRING AND PCL AND THE POLY WAS SWAPPED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 18184333 ↗
• MalfunctionJan 11, 2023Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16139835 ↗
• InjuryNov 29, 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: Pain; Thrombosis/Thrombus

  MAUDE report 12883825 ↗
• MalfunctionJul 13, 2021Device 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12159624 ↗
• InjuryJul 13, 2021Naturally Worn; Naturally Worn

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 12158850 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY APPROXIMATELY 1.5 YEARS AGO. SUBSEQUENTLY, THE PATIENT HAS BEEN EXPERIENCING PAIN AND SWELLING SINCE HER PROCEDURE. SHE HAS UNDERWENT TWO MANIPULATIONS ON UNKNOWN DATES, REMOVING SCAR TISSUE WITH NO RELIEF. PATIENT HAD METAL ALLERGY TESTING AND IS HIGHLY REACTIVE TO NICKEL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 11768809 ↗
• InjuryMar 8, 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: Wound Dehiscence

  MAUDE report 11439776 ↗
• InjuryOct 21, 2020Adverse 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 AND THREE WEEKS POST IMPLANTATION DUE TO INFECTION. THE INFECTION WAS CONFIRMED APPROXIMATELY ONE-YEAR POST OP. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 10711740 ↗