Persona® Trabecular Metal® 42-5028-074-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024230866), received between Apr 29, 2021 and Sep 15, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT AFTER OPENING THE BOX FOR THE IMPLANT, A LONG PIECE OF WHAT APPEARS TO BE HUMAN HAIR WAS SEEN CAUGHT INSIDE, EXTENDING INSIDE THE BOX AND CAUGHT WITHIN THE PAPER SEAL AND THE PLASTIC CONTAINER. SINCE THERE WAS ANOTHER FURTHER SEAL TO CONTAIN THE ACTUAL IMPLANT, THE IMPLANT WAS OPENED AND USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17757162 ↗
• InjurySep 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, THE TIBIAL, FEMORAL, AND PATELLAR COMPONENTS WERE REVISED APPROXIMATELY 1 YEAR LATER DUE TO POSSIBLE ASEPTIC LOOSENING. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 15334040 ↗
• InjuryJul 25, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. APPROXIMATELY TWO YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN AND PATELLAR MALTRACKING. IT WAS NOTED THAT THE FEMORAL ROTATION OF THE IMPLANT WAS A CONTRIBUTING FACTOR TO THE EVENT. DUE DILIGENCE IS IN PROCESS FOR THIS EVENT; AT THE TIME OF THIS REPORT NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15092556 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 10 DAYS POST IMPLANTATION, THE PATIENT WAS DIAGNOSED WITH A DEEP VEIN THROMBOSIS. THE PATIENT WAS PLACED ON ELIQUIS FOR TREATMENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11747211 ↗