Persona® The Personalized Knee® OsseoTi® 42-5350-079-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024631977), received between May 13, 2025 and Aug 10, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that the patient underwent a right knee arthroplasty revision to address tibial fibrous ingrowth approximately two (2) years post-operatively.Attempts have been made and no further information has been provided.

  Patient problems: Arthrofibrosis; Aseptic loosening

  MAUDE report 50192481 ↗
• MalfunctionJul 17, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25857582 ↗
• MalfunctionFeb 12, 2026Positioning Failure

  IT WAS REPORTED THAT WHEN USING PERSONA OSSEOTI 0-DEGREE TIBIAL COMPONENT, THE ARTICULAR SURFACE DID NOT FIT. THERE WAS NO PATIENT IMPACT, SURGICAL TECHNIQUE UTILIZED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321621 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT KNEE SWELLING AND LIMITED RANGE OF MOTION APPROXIMATELY ONE (1) MONTH FOLLOWING RIGHT KNEE ARTHROPLASTY. THE PATIENT WAS TREATED WITH A STEROID AND COMPRESSION SLEEVE TO ADDRESS INFLAMMATION. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Loss of Range of Motion; Swelling/ Edema

  MAUDE report 22806304 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 5 WEEKS POST-OPERATIVE, THE PATIENT BEGAN TO EXPERIENCE SEVERE PAIN APPROXIMATELY. AT THE NINE MONTH POST-OPERATIVE FOLLOW-UP APPOINTMENT, THE PATIENT REPORTED SEVERE PAIN AND DIFFICULTIES WITH AMBULATION AND ADLS. ALL RADIOGRAPHIC IMAGING DISPLAYED NO SIGNIFICANT FINDINGS AND THE KNEE WAS STABLE UPON ASSESSMENT. A BRACE WAS GIVEN AT THE 9 MONTH FOLLOW-UP TO RULE OUT ANY INSTABILITY THAT COULD BE CONTRIBUTING TO THE ONGOING PAIN. ALL PRODUCTS REMAIN IMPLANTED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 22009042 ↗