ATTUNE 1504-11-203Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295042020), received between Sep 29, 2022 and Jun 27, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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.

• InjuryJun 27, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT RECEIVED A PRESS FIT KNEE. DOCTOR REPORTED THAT IT WAS LOOSE, SO SURGEON REVISED IT. THERE WAS LOOSENING OF FEMUR AT NON CEMENTED INTERFACE. UNKNOWN CEMENT WAS USED. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22344864 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16709147 ↗
• InjuryOct 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTENT PAIN IN RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019, DATE OF EVENT: (B)(6) 2022, (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA AND DIAGNOSTIC INTERVENTION (SCINTIGRAPHY AND X-RAYS).

  Patient problems: Pain

  MAUDE report 15612693 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTENT PAIN IN RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019; DATE OF EVENT: (B)(6) 2022; (RIGHT KNEE). TREATMENT: DIAGNOSTIC INTERVENTIONS (SCINTIGRAPHY AND X-RAYS) AND MANIPULATION UNDER ANESTHESIA.

  Patient problems: Pain

  MAUDE report 15502013 ↗