ATTUNE 2504-40-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295442882), received between Jul 15, 2019 and Sep 22, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break; Material Deformation

  It was reported that device was broken and stripped during case.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855694 ↗
• MalfunctionSep 16, 2026Material Deformation; Illegible Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794492 ↗
• MalfunctionOct 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT FEMORAL BOLT WORN AND OLD. NO LONGER WILL IT THREAD TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23249346 ↗
• MalfunctionSep 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE THREADS ON THE BROACH BOLT WERE DISCOVERED TO BE DEFECTIVE AS THE BOLT WOULD NOT LOCK THE SLEEVE TO THE FEMUR TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953895 ↗
• MalfunctionJun 10, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE BOLT GOT CROSS-THREADED IN THE PROCESS OF TIGHTENING IT TO THE BROACH AND THE THREADS WERE DAMAGED SO THAT IT WOULD NO LONGER TIGHTEN FULLY. THE OTHER BOLT IN THE SET WAS USED INSTEAD AND THE CASE WAS FINISHED WITHOUT FURTHER INCIDENT. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176097 ↗
• MalfunctionMay 1, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TRIAL ATTUNE SLEEVE BROACH BOLT WILL NO LONGER THREAD INTO THE SLEEVE. THE THREADS ON THE BOLT WERE STRIPPED. NO TIME WAS ADDED TO CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944333 ↗
• MalfunctionJan 23, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE FEMORAL BROACH TRAILING BOLTS WOULD NOT STAY LOCKED INTO THE FEMORAL BROACH BECAUSE THE THREADS WERE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223597 ↗
• MalfunctionJan 23, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE FEMORAL BROACH TRIALING BOLTS WOULD NOT STAY LOCKED INTO THE FEMORAL BROACH BECAUSE THE THREADS WERE STRIPPED. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223596 ↗
• MalfunctionMar 7, 2024Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THREADS ON BOLT ARE STRIPPED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES. PATIENT STATUS/ OUTCOME / CONSEQUENCES ? NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF ? NONE. DEVICE IN POSSESSION OF? NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.? TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855620 ↗
• MalfunctionOct 18, 2023Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE ATTUNE REVISION BROACH BOLT IS CROSS THREADED AND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957009 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT THE 45 FEMORAL BROACH AND BOLTS COMPATIBLE WITH 45 BROACH ARE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640961 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT THE 45 FEMORAL BROACH AND BOLTS COMPATIBLE WITH 45 BROACH ARE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640937 ↗
• MalfunctionApr 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WERE NO BROKEN PIECES FROM THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815153 ↗
• MalfunctionMar 24, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THREADS ON BOLT APPEAR TO HAVE FLATTENED. THE TRIAL WOULD NOT HOLD A SCREW. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13888200 ↗
• MalfunctionAug 26, 2020Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE THREADS ON THE BROACH BOLT ARE WORN AND BOLT WILL NOT TIGHTEN. BOLT IS IN ONE PIECE AND WAS RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10456551 ↗
• MalfunctionMar 16, 2020Break; Device-Device Incompatibility; Material Twisted/Bent; Break; Device-Device Incompatibility; Material Twisted/Bent

  THE FEMORAL BROACH HANDLE WAS LOOSE AND WOULDN'T HOLD THE BROACHES AS SECURELY AS WOULD HAVE BEEN LIKED. THE T RATCHET HANDLE TORQUE LIMITER SEEMED BROKEN. THE 2 FEMORAL BROACH SCREWS WOULDN'T LOCK INTO FEMUR CORRECTLY. ALL INSTRUMENTS TAGGED BROKEN READY FOR RETURN. NO ADVERSE OUTCOME NOTED AS IN THE END CASE WENT WELL. SLIGHT EXTENSION OF CASE TIME BY 5 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 9837822 ↗
• MalfunctionJul 29, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH BOLT WOULD NOT THREAD INTO THE FEMORAL BROACH. SWITCHED TO SECOND BOLT AND IT WORKED FINE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8835958 ↗
• MalfunctionJul 15, 2019Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE ATTUNE REVISION FEMORAL SLEEVE BOLT THREADS WAS STRIPPED OUT, WOULD NOT ENGAGE BROACH. UNABLE TO OBTAIN LOT NUMBER, WORN OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8790906 ↗
• MalfunctionJul 15, 2019Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE ATTUNE REVISION FEMORAL SLEEVE BOLT THREADS WAS STRIPPED OUT, WOULD NOT ENGAGE BROACH. UNABLE TO OBTAIN LOT NUMBER, WORN OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8790904 ↗