Persona® The Personalized Knee® 42-5360-079-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024632158), received between Dec 30, 2024 and Aug 5, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient has experienced moderate to severe pain and difficulty with activities approximately one (1) year following a right knee arthroplasty. Patient was recommended to modify activities and shoe wear and to pursue physical therapy, deep tissue massage and weight loss.Attempts have been made, however, no additional information is available.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 50148105 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A CORTICOSTEROID INJECTION TO ADDRESS PAIN, SWELLING AND STIFFNESS APPROXIMATELY ONE (1) YEAR FOLLOWING RIGHT KNEE ARTHROPLASTY. HOWEVER, THE PATIENT CONTINUES TO EXPERIENCE PAIN AND HAS BEEN REFERRED FOR GENICULAR NERVE BLOCKS. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23844013 ↗
• InjuryJul 30, 2025Adverse 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: Ambulation or Postural Difficulties; Hypersensitivity/Allergic reaction; Pain; Weight Changes

  MAUDE report 22664270 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE APPROXIMATELY TWO (2) WEEKS FOLLOWING RIGHT KNEE ARTHROPLASTY TO ADDRESS WOUND DEHISCENCE ACCOMPANIED BY ECCHYMOSIS AND MODERATE EFFUSION AS WELL AS REPAIR THE PATIENT'S QUADRICEP TENDON. DURING THE PROCEDURE, A SUBCUTANEOUS HEMATOMA WAS EVACUATED AND THE VASTUS MEDIALIS WAS CLOSED WITH ONE LOOP. NO IMPLANTS WERE REMOVED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. IRRIGATION AND DEBRIDEMENT OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Ecchymosis; Hematoma; Joint effusion; Muscle/Tendon Damage; Pain; Wound Dehiscence

  MAUDE report 21366025 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 16 DAYS POST-OP, THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC FOR MILD REDNESS TO PROXIMAL INCISION AS A PROPHYLAXIS TREATMENT AND IT RESOLVED WITH NO FURTHER ALLEGATIONS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Erythema; Post Operative Wound Infection

  MAUDE report 21036281 ↗