ATTUNE 2511-01-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295437963), received between Dec 11, 2018 and Mar 8, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISTAL FEMUR FX OCCURRED WHILE BROACHING FOR FEMORAL SLEEVE.

  Patient problems: Bone Fracture(s)

  MAUDE report 11438842 ↗
• MalfunctionFeb 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  BROACH WAS DIFFICULT TO LOCK INTO POSITION WHEN IN SITU. 2 MINUTE DELAY TO THE PROCEDURE WITH NO HARM TO PATIENT.

  Patient problems: Not Applicable

  MAUDE report 9739460 ↗
• InjuryNov 26, 2019Connection Problem; Device-Device Incompatibility; Connection Problem; Device-Device Incompatibility

  COULD NOT GET FEMORAL TRIAL TO ENGAGE & LOCK TO BROACH WITH REVISION FEMORAL BROACH BOLT. TRIED BOTH BOLTS - NEITHER SUCCESSFUL. SCREWED IN AND TORQUED HOWEVER DID NOT LOCK ENOUGH TO MAINTAIN ROTATION. THIS MEANT THAT WE COULD NOT LOCK THE ROTATION OF THE FEMORAL TRIAL TO THE BROACH FOR REPLICATION OF REAL IMPLANT. THIS MEANT THE ROTATION OF THE IMPLANT WAS NOT ACCURATE AND FEMUR FRACTURED ON INSERTION OF IMPLANT. SURGEON REMOVED IMPLANT AND PLACED A CABLE THEN RE-IMPLANTED FEMUR WITH EVENTUAL SUCCESS. BOLTS WORKED WITH BROACHES ABOVE AND BEYOND THE 40MM BUT NOT THE 40MM ONE. 20 MINUTE DELAY TO THE PROCEDURE. PATIENT OUTCOME POST SURGERY: PATIENT POST OP XRAY LOOKED IN GOOD ALIGNMENT. SURGEON WAS HAPPY WITH OUTCOME. 2 CABLES PLACED AROUND FEMUR.

  Patient problems: Bone Fracture(s); Not Applicable

  MAUDE report 9378691 ↗
• MalfunctionDec 11, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING CADAVER TRAINING LAB THE JUMP FROM THE TIBIAL CONICAL REAMER TO THE 29MM TIBIAL BROACH WAS TOO LARGE AND THE GAPS BETWEEN THE TEETH ON THE TIBIAL BROACHES ARE TOO SMALL IN COMPARISON TO THE PREDICATE BROACHES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8151551 ↗