ATTUNE 1504-01-109Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295041382), received between May 26, 2021 and Nov 22, 2024 — classified as 4 injuries, 1 malfunction.

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

• MalfunctionNov 22, 2024Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  IT WAS REPORTED THAT LUG HOLES ON THE IMPLANT WERE POSTERIOR FROM THE HOLES DRILLED. IMPLANT COULD NOT SEAT . THEY SWITCHED TO A CEMENTED AND THE HOLES LINED UP. DOE: (B)(6) 2024 , AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20763590 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR EXTENSOR MECHANISM INSUFFICIENCY. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: (B)(6) 2024. (LEFT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18905465 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS AND ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION. DEPUY PRODUCTS USED (NO REVISION COMPLETED).

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 17069758 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE ARTHROFIBROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2021; DATE OF EVENT: (B)(6) 2021; (LEFT KNEE). TREATMENT: NONE.

  Patient problems: Adhesion(s)

  MAUDE report 15162693 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TKR ON (B)(6) 2021 WHERE AN ATTUNE UNCEMENTED TIBIAL COMPONENT AND AN ATTUNE UNCEMENTED FEMORAL COMPONENT WAS UTILISED. SURGEON MENTIONED THAT HE WAS REQUIRED TO UNDERTAKE MANIPULATION UNDER ANAESTHESIA (MUA). PATIENT CONSEQUENCE DESCRIPTION/ A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT: LIMITED ROM, STIFFNESS.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 11884077 ↗