Persona® Trabecular Metal® 42-5022-064-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024470101), received between Sep 30, 2019 and Mar 20, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION DUE TO PAIN AND PROGRESSION OF TIBIAL LUCENCY APPROXIMATELY TWO (2) YEARS POST-OPERATIVELY. DURING THE REVISION, ALL COMPONENTS WERE FOUND TO BE WELL-FIXED. ALL COMPONENTS EXCEPT THE PATELLA WERE REVISED FOR A TWO-STAGE REVISION DUE TO SUSPECTED INFECTION, ALTHOUGH INFECTION WAS RULED OUT POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 21652178 ↗
• 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 19819145 ↗
• InjuryApr 18, 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: Abscess; Bacterial Infection; Erosion; Hematoma; Joint effusion; Pain

  MAUDE report 19133127 ↗
• InjurySep 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY ONE YEAR, TEN MONTHS POST IMPLANTATION FOR PAIN AND FEMORAL LOOSENING. FEMORAL IMPLANT AND ARTICULAR SURFACE WERE REVISED. TIBIAL IMPLANT, TIBIAL STEM AND PATELLA WERE RETAINED. NO ADDTIONAL INFORMATION WAS MADE AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17765065 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 1.5 YEARS POST IMPLANTATION DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 17640950 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 9135002 ↗