ATTUNE 1504-11-204Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295042037), received between Feb 21, 2020 and Feb 17, 2023 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR OA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE IMPLANTS HAVE LOOSENED. A REVISION WILL BE PERFORMED SOON. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16397140 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE UNDISPLACED FRACTURE OF MEDIAL FEMORAL CONDYLE AT BASE OF PS BOX. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2021, (RIGHT KNEE). TREATMENT: REDUCTION OF FRACTURE AND INTUNED FIXATION WITH 3.5 LARGE SCREWS.

  Patient problems: Limb Fracture

  MAUDE report 15707696 ↗
• InjurySep 14, 2021Use of Device Problem; Use of Device Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PROGRESSIVE MAL-ALIGNMENT OF RIGHT KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE). TREATMENT: RADIOGRAPHS TAKEN OF KNEE.

  Patient problems: Pain

  MAUDE report 12467788 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE NONDISPLACED BONE FRACTURE OF MEDIAL FEMORAL CONDYLE - AT BASE OF THE PS BOX CUT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: OPEN REDUCTION OF FRACTURE WITH INTERNAL FIXATION USING 3.5 LARGE SCREWS X 3.

  Patient problems: Bone Fracture(s)

  MAUDE report 11870093 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN IN THE RIGHT KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: PAIN KILLERS ADMINISTERED.

  Patient problems: Pain

  MAUDE report 11141247 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HEMATOMA ON RIGHT KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: SURGICAL EVACUATION OF HEMATOMA.

  Patient problems: Hematoma; No Code Available

  MAUDE report 10863991 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND SLIGHTLY LIMITED FUNCTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2019; DATE OF EVENT: (B)(6) 2019; (RIGHT KNEE).

  Patient problems: Edema; Hematoma; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Thrombosis

  MAUDE report 9741683 ↗