Persona® Trabecular Metal® 42-5028-064-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024230774), received between May 23, 2022 and Nov 11, 2025 — classified as 5 injuries, 1 malfunction.

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

• InjuryNov 11, 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 LEFT KNEE SURGERY. APPROXIMATELY 3 YEARS POST-OP, THE PATIENT UNDERWENT A PATELLA RESURFACING AND POLY SWAP DUE TO PAIN. THE POLY WAS REVISED DUE TO STANDARD PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 23521675 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 4 MONTHS POST IMPLANTATION OF A LEFT KNEE TOTAL ARTHROPLASTY, THE PATIENT EXPERIENCED PAIN. X-RAYS WERE TAKEN AND IDENTIFIED TIBIAL COMPONENT LOOSENING, AND RADIOLUCENT LINES TO THE DISTAL FEMORAL SIDE. THE PATIENT HAS BEEN INDICATED FOR A FUTURE REVISION. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND NONE IS AVAILABLE.

  Patient problems: Aseptic loosening; Pain; Radiolucent Lines

  MAUDE report 22723513 ↗
• MalfunctionOct 8, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT WHEN THE SURGEON OPENED THE PACKAGING OF A PROSTHESIS PRIOR TO A KNEE PROCEDURE, GLUE-LIKE DEBRIS WAS NOTED IN THE STERILE PACKAGING. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396222 ↗
• 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 ARTHROPLASTY. SUBSEQUENTLY, PATIENT UNDERWENT A POLY SWAP DUE TO ARTHROFIBROSIS. PATIENT HAD BETTER RANGE OF MOTION FOR A TIME BUT THEN IT DECREASED DUE TO FIBROUS TISSUE BUILDUP. A FURTHER REVISION WAS PERFORMED TO REMOVE THE ENTIRE KNEE AND REPLACE WITH A REVISION SYSTEM. NO FURTHER PATIENT CONSEQUENCES HAVE BEEN REPORTED.

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

  MAUDE report 19214908 ↗
• InjuryOct 10, 2023Unstable; Unstable

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

  Patient problems: Failure of Implant

  MAUDE report 17906552 ↗
• InjuryMay 23, 2022Unstable; Unstable

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE SEVENTEEN MONTHS POST IMPLANTATION DUE TO INSTABILITY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 14474716 ↗