Persona® The Personalized Knee® 42-5360-064-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024632073), received between Oct 15, 2024 and Jun 1, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Implant subsidence” (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.

• MalfunctionJun 1, 2026Malposition of Device

  IT WAS REPORTED THAT DURING KNEE ARTHROPLASTY WHILE THE SURGEON WAS IMPLANTING THE TIBIAL TRAY, THE IMPLANT SHIFTED BACKWARD BY APPROXIMATELY 3 MILLIMETERS DESPITE CANAL PREPARATION. THERE WERE NO OTHER INTRAOPERATIVE COMPLICATIONS AND THE TIBIAL TRAY REMAINED IN PLACE. NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED AND NO MEDICAL OR SURGICAL INTERVENTION TO CORRECT THE OUTCOME HAS BEEN PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351350 ↗
• InjuryMay 29, 2025Implant subsidence; Implant subsidence

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY THREE (3) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN AND INSTABILITY. DIAGNOSTIC IMAGES CONFIRMED THAT THE TIBIAL COMPONENT HAD SUNK BY THREE (3) MILLIMETERS. A REVISION SURGERY WAS PERFORMED TO REPLACE THE AFFECTED TIBIAL TRAY WITHOUT COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 22106058 ↗
• InjuryOct 15, 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: Thrombosis/Thrombus

  MAUDE report 20455027 ↗