Persona® The Personalized Knee® 42-5360-067-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024632097), received between Apr 23, 2024 and May 18, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.

• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL STUDY THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY AND EXPERIENCED SEVERE KNEE PAIN REQUIRING NON-NARCOTIC PAIN MEDICATION APPROXIMATELY 1 YEAR POST-IMPLANTATION. THE PATIENT REQUIRED NON-NARCOTIC PAIN MEDICATION; ALL IMPLANTS REMAINED INTACT, THE PATIENT WAS REPORTEDLY VERY SATISFIED, AND NO FURTHER KNEE COMPLICATIONS WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 25200927 ↗
• MalfunctionOct 17, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT IT LOOKED LIKE WHITE DEBRIS ON THE METAL POST. THE PRODUCT WAS NOT USED. NO PATIENT HARM OR IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322066 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Ambulation or Postural Difficulties; Pain; Radiolucent Lines

  MAUDE report 23316578 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT DEVELOPED A DEEP VEIN THROMBOSIS AND WAS TREATED WITH ELIQUIS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19166604 ↗