Persona® The Personalized Knee® 42-5360-071-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024632103), received between Dec 10, 2024 and Oct 24, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device label look-alike” (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.

• InjuryOct 24, 2025Off-Label Use; Device packaging look-alike; Device label look-alike; Off-Label Use; Device packaging look-alike; Device label look-alike

  IT WAS REPORTED THROUGH A USER REPORT THAT DURING AN LEFT TOTAL KNEE ARTHROPLASTY, THE SURGEON INTENDED TO USE A PRESS-FIT, NONCEMENTED SYSTEM. HOWEVER, A CEMENTED TIBIAL PLATE WAS MISTAKENLY IMPLANTED INTO THE PATIENT RATHER THAN A NONCEMENTED PLATE, AND NO CEMENT WAS USED. SUBSEQUENTLY, THE PATIENT WAS REVISED 4 DAYS LATER TO CORRECT THE TIBIAL COMPONENT. REPORTER CLAIMS THAT HUMAN ERROR OCCURRED BECAUSE THE PACKAGING OF THE TWO DIFFERENT DEVICE LINES, CEMENTED VS NONCEMENTED, ARE TOO SIMILAR. THERE IS NO OTHER ALLEGED MALFUNCTION AGAINST THE DEVICE, AND PATIENT DID NOT EXPERIENCE ANY OTHER HARM OR IMPACT AS A RESULT OF THE INCORRECT PLATE BEING IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ALL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378785 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 1 MONTH POST IMPLANTATION, THE PATIENT WAS DIAGNOSED WITH PERONEAL DEEP VEIN THROMBOSIS THROUGH ULTRASONIC IMAGING. THE PATIENT WAS PRESCRIBED ELIQUIS AND ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20891780 ↗