Persona® Trabecular Metal® 42-5022-060-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024470057), received between Sep 15, 2023 and Oct 25, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DRAINAGE FROM THE INCISION APPROXIMATELY THREE (3) MONTHS FOLLOWING A LEFT KNEE ARTHROPLASTY. THE PATIENT WAS INSTRUCTED TO APPLY ANTIBIOTIC OINTMENT, KEEP THE INCISION COVERED AND WAS PRESCRIBED AN ANTIBIOTIC PROPHYLACTICALLY. THE PATIENT'S DRAINAGE WAS REPORTEDLY RESOLVED SEVEN (7) MONTHS LATER. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Impaired Healing

  MAUDE report 20534061 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DRAINAGE FROM THE INCISION APPROXIMATELY THREE (3) MONTHS FOLLOWING A LEFT KNEE ARTHROPLASTY. THE PATIENT WAS INSTRUCTED TO APPLY ANTIBIOTIC OINTMENT, KEEP THE INCISION COVERED AND WAS PRESCRIBED AN ANTIBIOTIC PROPHYLACTICALLY. THE PATIENT'S DRAINAGE WAS REPORTEDLY RESOLVED SEVEN (7) MONTHS LATER. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Impaired Healing

  MAUDE report 20533996 ↗
• InjurySep 15, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO THE FEMORAL IMPLANT BEING IN VALGUS ALIGNMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 17756592 ↗