Persona® Trabecular Metal® 42-5022-066-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024470118), received between Feb 6, 2023 and Dec 30, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ONE (1) YEAR POST-IMPLANTATION, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO RESURFACE THE NATIVE PATELLA DUE TO INFECTION. A PATELLAR COMPONENT WAS IMPLANTED AND ALL INITIAL DEVICES REMAINED INTACT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 21036821 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. AT 3 MONTHS POST OP, THE PATIENT WAS PAIN FREE WITH 120 DEGREES FLEXION. APPROXIMATELY 4 MONTHS POST IMPLANTATION, THE PATIENT PRESENTED WITH KNEE PAIN. THE ORIGINAL REASON FOR REVISION WAS FOR SUSPECTED INFECTION, HOWEVER, THE SURGEON MENTIONED THE KNEE DID NOT LOOK INFECTED WHEN REMOVING THE PROSTHESIS. THE SURGEON TOOK 6 SWABS, 3 ON DISTAL FEMUR AND 3 ON PROXIMAL TIBIA. WHEN REMOVING THE TIBIA, IT WAS NOTED THAT THE MEDIAL TM PEG HAD SNAPPED PRIOR TO ATTEMPTS TO REMOVE. THE BONE INGROWTH ON THE UNDERSIDE OF TM TIBIA WAS SMALL. THE PEG THAT WAS LEFT IN PATIENT HAD BONE INGROWTH. IT WAS NOTED THAT THE MEDIAL TM PEG IS NOT PERPENDICULAR TO THE BASEPLATE IN X-RAYS. ADDITIONALLY, METAL DEBRIS SEEN IN X-RAYS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 16860494 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 2.5 MONTHS IMPLANTATION, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Discomfort; Loss of Range of Motion; Scar Tissue

  MAUDE report 16308612 ↗