ATTUNE 2511-11-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295435778), received between Dec 11, 2018 and Sep 9, 2021 — classified as 4 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 18, 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.

• MalfunctionSep 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 45 SLEEVE BROACH WILL NOT ATTACH TO THE TRIAL TRAY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446638 ↗
• MalfunctionJul 27, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  12X60 ATTUNE REVISION STEM SHEARED OFF A 45MM TIBIAL BROACH, LEAVING BOTH ITEMS UNUSABLE AND NEEDING REPLACEMENT. SURGEON WAS BROACHING THE TIBIA WHEN IT HAPPENED. NO REAL DELAY TO THE CASE BUT HE DID HAVE TO RETRIEVE THE BROKEN STEM TRIAL FROM THE TIBIAL CANAL. EVERYTHING WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235524 ↗
• MalfunctionNov 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  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 10868245 ↗
• 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 8151789 ↗