Persona® The Personalized Knee® 42-5360-067-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024632080), received between Aug 5, 2024 and Jul 28, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryJul 28, 2026Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that the patient is tentatively awaiting a left knee arthroplasty revision to address tibial component loosening, pain, swelling and instability after a fall.Initial operative notes noted no intraoperative complications.Attempts have been made and no further information has been provided.

  Patient problems: Aseptic loosening; Joint Laxity; Osteolysis; Pain; Radiolucent Lines; Swelling/ Edema

  MAUDE report 50053723 ↗
• InjuryNov 10, 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: Crepitus; Extraskeletal ossification; Numbness; Pain

  MAUDE report 23509602 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED DEEP VEIN THROMBOSIS ACCOMPANIED BY PAIN AND LOWER LEG SWELLING APPROXIMATELY ONE (1) WEEK FOLLOWING LEFT KNEE ARTHROPLASTY. THE PATIENT STAYED OVERNIGHT AT THE HOSPITAL AND TREATED WITH ELIQUIS WHILE INPATIENT AND WAS PRESCRIBED XARELTO WHEN RELEASED. THE PATIENT APPEARED TO BE IMPROVING WHEN SEEN TWO (2) WEEKS LATER. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cyst(s); Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 21055636 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT REPORTED DIZZINESS, NAUSEA, FATIGUE, SHORTNESS OF BREATH, AND HYPOTENSION ABOUT THREE WEEKS POST TKA. THE PATIENT AND WAS TRANSFERRED TO THE EMERGENCY ROOM VIA EMS. A CT SCAN CONFIRMED A NONOCCLUSIVE SUB-SEGMENTAL PULMONARY EMBOLISM WITH LEFT UPPER LOBE AND WAS HOSPITALIZED FOR TWO DAYS FOR ANTICOAGULATION THERAPY. THE PATIENT WAS DISCHARGED HOME TWO DAYS LATER, PRESCRIBED ON APIXABAN FOR THREE MONTHS. AT THE THREE MONTH FOLLOW-UP, THE PATIENT WAS PROGRESSING WELL AND REMAINED SATISFIED WITH ALL IMPLANTS IN PLACE.

  Patient problems: Dizziness; Dyspnea; Fatigue; Low Blood Pressure/ Hypotension; Nausea; Pulmonary Embolism

  MAUDE report 19911627 ↗