Persona® The Personalized Knee® 42-5360-075-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024632127), received between Jul 30, 2025 and Dec 9, 2025 — classified as 2 injuries.

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.

• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Fluid Discharge; Impaired Healing; Muscle/Tendon Damage; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 23759799 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A STUDY THAT APPROXIMATELY 1 MONTH POST IMPLANTATION OF A LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS DIAGNOSED WITH CELLULITIS AND WAS PRESCRIBED ANTIBIOTICS, AS WELL AS UNDERWENT A WOUND DEBRIDEMENT, IRRIGATION, AND WOUND CARE. THE PATIENT WAS REPORTED AS FULLY HEALED APPROXIMATELY 6 WEEKS LATER. DEVICES REMAIN IMPLANTED. ATTEMPTS WERE MADE AND ALL AVAILABLE INFORMATION WAS PROVIDED.

  Patient problems: Cellulitis

  MAUDE report 22668483 ↗