Persona® Trabecular Metal® 42-5028-066-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024230798), received between Apr 28, 2021 and Jul 31, 2026 — classified as 4 injuries, 2 malfunctions.

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

• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a knee arthroplasty revision to address tibial tray migration resulting in instability. Upon removal of the components, femoral osteolysis around the metaphyseal region of the femur was identified that extended to the posterior condyles both medially and laterally. All components were revised and replaced.Attempts have been made, however, no additional information is available.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 50100380 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS REVISED ONE YEAR, NINE MONTHS POST PROCEDURE DUE TO PAIN AND STIFFNESS (ASEPTIC). FEMORAL, TIBIAL AND BEARING WERE REVISED. THE PATELLA WAS NOT REVISED.

  Patient problems: Pain

  MAUDE report 21277397 ↗
• MalfunctionDec 2, 2024Malposition of Device; Malposition of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824957 ↗
• MalfunctionJul 31, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17423549 ↗
• 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; Pain; Swelling/ Edema

  MAUDE report 16553273 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO ARTHROFIBROSIS THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA TWO MONTHS POST TOTAL LEFT KNEE ARTHROPLASTY. AFTERWARD, THE STIFFNESS AND LIMITED FLEXION PREVIOUSLY REPORTED WERE NOTED TO BE RESOLVED.

  Patient problems: Adhesion(s); Arthritis; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 11739667 ↗