ATTUNE 2511-01-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295437956), received between Dec 11, 2018 and Dec 9, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FEMORAL BROACH IS DAMAGED. THE INTERNAL THREAD IS WORN. IT DOESN'T LOCK IN ROTATION. THERE WAS A 10 MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880625 ↗
• MalfunctionJan 3, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT BROACH ADAPTOR BOLT NOT ENGAGING IN FEMORAL BROACH DURING ATTUNE REVISION CASE. UPON INSPECTION THE INTERNAL THREAD OF THE 35MM FEMORAL BROACH IS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091083 ↗
• MalfunctionAug 12, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FEMORAL BROACH TRIAL BOLT WAS STRIPPED AND COULD NOT BE REMOVED FROM FEMORAL BROACH. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8885222 ↗
• MalfunctionMar 7, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A TOTAL KNEE REVISION, THE SURGEON WAS BROACHING UP TO THE DESIRED FEMORAL BROACH SIZE WHEN HE WAS NOT ABLE TO EXTRACT THE 35MM BROACH. WHEN THE SURGEON ATTEMPTED TO REMOVE THE BROACH DURING A HIT WITH THE MALLET THE BROACH HANDLE WOULD DISCONNECT FROM THE BROACH. AT THAT POINT, THE SURGEON USED THE SECOND BROACH HANDLE IN THE SET WHEN HE GOT THE SAME RESULT AS BEFORE. HITTING THE BROACH WITH THE MALLET DURING EXTRACTION OF THE 35MM BROACH WOULD CAUSED IT THE BROACH HANDLE TO DISENGAGED LEAVING THE BROACH IN THE PATIENT. UNABLE TO REMOVE THE BROACH WITH THE BROACH HANDLES THE 1-3 BROACH ADAPTER WAS THREADED ONTO THE BROACH THEN USED AS A HITTING SURFACE FOR THE MALLET TO GET THE BROACH OUT. AS A RESULT THE 3-1 BROACH ADAPTER NEEDS TO BE REPLACED BECAUSE IT WAS BENT FROM REMOVING THE 35MM BROACH. NO PIECES OF THE INSTRUMENTS BROKE OFF DURING THE PROCEDURE, THEREFORE, NO PIECES HAD TO BE RETRIEVED. ALL PARTS ARE BEING SENT BACK TO DEPUY.

  Patient problems: No Code Available

  MAUDE report 8400018 ↗
• 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 8151595 ↗