Persona® Trabecular Metal® 42-5022-064-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024470095), received between May 4, 2021 and Jan 13, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 3.5 YEARS POST-OP, THE PATIENT WAS EXPERIENCING PAIN WITHOUT RELIEF FROM PHYSIOTHERAPY, A PAIN MANAGEMENT SPECIALIST, AND REHABILITATION. IMAGING REVEALED INCREASED UPTAKE AT THE PATELLA AND MEDIAL TIBIAL AREA. SUBSEQUENTLY, THE PATIENT WAS REVISED. ALL COMPONENTS WERE REVISED. THERE WAS NO LOOSENING SEEN, HOWEVER, THE SURGEON NOTED AREAS OF SOFTER BONE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 24052775 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Fall

  MAUDE report 18875437 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. ONE WEEK POST IMPLANTATION, THE PATIENT DEVELOPED WOUND DRAINAGE COMPLICATIONS REQUIRING APPLICATION OF A KNEE IMMOBILIZER. TWO MONTHS POST IMPLANTATION THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS AND LIMITED FLEXION. THE PATIENT CONTINUED TO REPORT STIFFNESS AND WAS PLACED IN A SPLINT. ONE MONTH AFTER THE MANIPULATION UNDER ANESTHESIA, THE PATIENT UNDERWENT AN OPEN RESECTION FOR SCAR TISSUE DUE TO ARTHROFIBROSIS. THE PATIENT WAS ULTIMATELY REVISED APPROXIMATELY TEN MONTHS POST IMPLANTATION DUE TO ONGOING PAIN, DIFFICULTY AMBULATING, AND ARTHROFIBROSIS. DURING THE REVISION, EXTENSIVE SCAR TISSUE WAS NOTED AS WELL AS A PSEUDO MENISCUS FORMATION CIRCUMFERENTIALLY AROUND THE JOINT. THE FEMORAL COMPONENT AND ARTICULAR SURFACE WERE EXCHANGED AND THE PATELLA WAS RESURFACED WITHOUT COMPLICATION. THE TIBIAL COMPONENT REMAINS IMPLANTED.

  Patient problems: Impaired Healing; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 12576660 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY APPROXIMATELY 1.5 YEARS AGO. SUBSEQUENTLY, THE PATIENT HAS BEEN EXPERIENCING PAIN AND SWELLING SINCE HER PROCEDURE. SHE HAS UNDERWENT TWO MANIPULATIONS ON UNKNOWN DATES, REMOVING SCAR TISSUE WITH NO RELIEF. PATIENT HAD METAL ALLERGY TESTING AND IS HIGHLY REACTIVE TO NICKEL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 11768810 ↗