Persona® Trabecular Metal® 42-5028-062-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024230750), received between Apr 17, 2023 and Sep 4, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ELEVEN MONTHS POST IMPLANTATION DUE TO METAL ALLERGIES. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20134138 ↗
• InjuryMar 11, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE TO ADDRESS PAIN, SWELLING AND INSTABILITY THAT WAS INTERFERING WITH RANGE OF MOTION APPROXIMATELY ONE YEAR POST-OPERATIVELY. THE SURGEON REPORTED THAT THE TIBIAL ROTATION DID NOT MATCH THE CORRECT PLACEMENT FOR A MEDIAL CONGRUENT BEARING AS THE SOFT TISSUES WERE TOO TIGHT TO ALLOW COMPONENT ARTICULATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Joint effusion; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 18882005 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY NINE MONTHS POST-IMPLANTATION, THE PATIENT HAD RECURRENT HEMARTHROSIS. LEADING TO LEFT KNEE ARTHROSCOPY, DEBRIDEMENT, LYSIS, AND ADHESIONS. DURING THE PROCEDURE FLUID WAS SENT TO MICROBIOLOGY FOR CELL COUNT AND GRAM STAIN CULTURE. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION OR OUTCOMES PROVIDED.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Hemorrhage/Blood Loss/Bleeding; Joint effusion; Loss of Range of Motion; Pain; Synovitis

  MAUDE report 16750917 ↗