Persona® The Personalized Knee® OsseoTi® 42-5350-071-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024631939), received between Jul 24, 2024 and Sep 22, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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.

• MalfunctionSep 22, 2026Packaging Problem

  It was reported that prior to an initial total knee arthroplasty, the implant packaging was found to be warped. The product was not used. No patient impact or adverse events have been reported as a result of the malfunction. All available information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858856 ↗
• InjuryNov 17, 2025Biocompatibility; Biocompatibility

  NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 23572942 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED DEEP VEIN THROMBOSIS APPROXIMATELY SIX (6) DAYS FOLLOWING RIGHT KNEE ARTHROPLASTY AND REQUIRED ANTICOAGULATION THERAPY. REPORTEDLY, THE PATIENT HAS SINCE IMPROVED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED DURING THE INITIAL PROCEDURE. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19819172 ↗