ATTUNE 2546-00-404Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295492023), received between Feb 19, 2019 and Nov 19, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2020Off-Label Use; Device-Device Incompatibility; Material Twisted/Bent; Off-Label Use; Device-Device Incompatibility; Material Twisted/Bent

  SURGEON PERFORMING REVISION KNEE WITH ATTUNE REVISION SYSTEM. FOLLOWING REAMING OF TIBIAL IM CANAL AND PREPARATION OF PROXIMAL TIBIA WITH SEQUENTIAL BROACHES THE BELOW BROACHES BECOME STUCK/WEDGED INTO THE TIBIA AND WHILST SURGEON ATTEMPTED TO EXTRACT THE BROACH WITH THE BROACH HANDLES THE COUPLINGS ON THE HANDLES WHICH ATTACH TO THE BROACHES WERE DISENGAGING WITH HEAVY MALLET BLOWS. SUCCESSFULLY EXTRACTED THE BROACH USING ADAPTOR TRIAL EXTRACTOR (THREADED INTO BROACH FEMALE RECESS). THIS WAS CROSS-THREADED AND NOW STUCK IN THE SIZE 45 TIBIAL BROACH (SURGEON AWARE THIS INSTRUMENT NOT DESIGNED FOR BROACH EXTRACTION BUT REMAINED THE ONLY OPTION TO ATTEMPT EXTRACTION OF THE TIBIAL BROACH. SURGERY COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION REQUIRED. NO FURTHER INFO AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 10868239 ↗
• MalfunctionFeb 19, 2019Break; Break

  IT WAS REPORTED THAT THE ATTUNE REVISION 29MM SLEEVE BROACH GOT STUCK IN THE TIBIA. BOTH BROACH HANDLE KEPT RELEASING ON EXTRACTION. THE SMALL END OF THE EXTRACTOR ROD WAS INSERTED INTO THE BROACH AND A CROSSBAR WAS PUT THROUGH THAT TO EXTRACT THE SLEEVE. TRYING TO GET THE ROD OUT OF THE BROACH AND THE TIP BROKE OFF INSIDE. THE 37MM BROACH WAS INSERTED NEXT AND IT GOT STUCK ALSO. BOTH BROACH HANDLES KEPT RELEASING. WITH THE EXTRACTION ROD BROKEN THE SURGEON SCREWED THE TRIAL RP BASE PLATE ONTO THE BROACH. TRIED EXTRACTING THE WHOLE CONSTRUCT WITH THE SYSTEM HANDLE AND THE BOX ADAPTER. THE SYSTEM HANDLE KEPT RELEASING ALSO. IT EVENTUALLY WAS ABLE TO BE WORKED OUT WITH THIS CONSTRUCT.

  Patient problems: Not Applicable

  MAUDE report 8349618 ↗