Persona® The Personalized Knee® OsseoTi® 42-5350-071-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024631922), received between Oct 23, 2024 and Feb 11, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Implant subsidence” (2 reports).

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.

• MalfunctionFeb 11, 2026Implant subsidence

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. AT THE 3 MONTH FOLLOW UP, THE PATIENT REPORTED MILD INSTABILITY WHEN LOADING THE LEFT ANKLE LIMITING HER MOBILITY. X-RAYS CONFIRMED MILD SUBSIDENCE OF THE TIBIAL COMPONENT INTO VALGUS POSITION. AN EXAM REVEALED MILD LAXITY WITH VARUS/VALGUS STRESS BUT FULL AND PAIN-FREE RANGE OF MOTION. THE PATIENT STATED SHE WAS STILL PLEASED WITH HER SURGERY AND DID NOT WANT TO PURSUE REVISION TO CORRECT THE VALGUS DEFORMITY AT THAT TIME. A KNEE BRACE WAS OFFERED FOR STABILITY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Deformity/ Disfigurement; Joint Laxity

  MAUDE report 24315168 ↗
• MalfunctionOct 15, 2025Implant subsidence; Implant subsidence

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. AT THE 3 MONTH FOLLOW UP, THE PATIENT REPORTED MILD INSTABILITY WHEN LOADING THE LEFT ANKLE LIMITING HER MOBILITY. X-RAYS CONFIRMED MILD SUBSIDENCE OF THE TIBIAL COMPONENT INTO VALGUS POSITION. AN EXAM REVEALED MILD LAXITY WITH VARUS/VALGUS STRESS BUT FULL AND PAIN-FREE RANGE OF MOTION. THE PATIENT STATED SHE WAS STILL PLEASED WITH HER SURGERY AND DID NOT WANT TO PURSUE REVISION TO CORRECT THE VALGUS DEFORMITY AT THAT TIME. A KNEE BRACE WAS OFFERED FOR STABILITY.

  Patient problems: Ambulation or Postural Difficulties; Deformity/ Disfigurement; Joint Laxity

  MAUDE report 23300222 ↗
• InjuryAug 5, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Aseptic loosening; Pain; Radiolucent Lines

  MAUDE report 22723516 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LIMITED RANGE OF MOTION AND STIFFNESS A LITTLE OVER ONE (1) MONTH FOLLOWING LEFT KNEE ARTHROPLASTY. THE PATIENT WAS PRESCRIBED NAPROXEN TO TREAT PES BURSITIS AND UNDERWENT A MANIPULATION UNDER ANESTHESIA TO TREAT ARTHROFIBROSIS. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. MANIPULATION NOTES NOTED NO COMPLICATIONS.

  Patient problems: Bursitis

  MAUDE report 20517684 ↗