ATTUNE 2504-40-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295438250), received between Mar 7, 2019 and Jan 31, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2020Material Twisted/Bent; Material Twisted/Bent

  SURGEON TRIED TO OVER-TIGHTEN SCREWS ATTACHING THE 1-3 BROACH ADAPTER TO SIZE 3 AP CUTTING BLOCK. IN DOING SO, APPEARS TO HAVE CROSS-THREADED THE LEFT HAND SCREW OF THE BROACH ADAPTER AND THREAD ON INSIDE OF AP CUTTING BLOCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9656016 ↗
• MalfunctionMar 7, 2019Material Twisted/Bent; Material Twisted/Bent

  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 8399929 ↗