Persona® Trabecular Metal® 42-5028-058-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024230712), received between Aug 9, 2023 and Apr 18, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS ALSO REVISED DUE TO IMPLANT LOOSENING OF BOTH COMPONENTS NOT ONLY FEMORAL COMPONENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 21866730 ↗
• InjuryAug 9, 2023Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR THREE AND A HALF MONTHS POST IMPLANTATION DUE TO INSTABILITY. THE PATIENT HAD BOTH PAIN AND SWELLING PRIOR TO THE REVISION. THE SURGEON DOESN'T BELIEVE THAT THE ORIGINAL COMPONENTS (OR FAILURE OF) CONTRIBUTED TO THE FALL(S) OF THE PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Fall; Pain; Swelling/ Edema

  MAUDE report 17490796 ↗