ATTUNE 2511-11-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295435761), received between Jul 3, 2018 and Oct 23, 2023 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL TRAY IS STRIPPED AND LOCKED ONTO THE BROACH. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985209 ↗
• MalfunctionFeb 13, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE RP REVISION BASEPLATE AND TIBIAL SLEEVE TRIAL WILL NOT SEPARATE. SCREW MAY BE STRIPPED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16367267 ↗
• MalfunctionOct 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL IS BROKEN. THERE WAS 20 MINUTES SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632743 ↗
• 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 10868246 ↗
• MalfunctionOct 15, 2020Mechanical Jam; Mechanical Jam

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE MALE PART OF THE STEM TRIAL THAT THREADS INTO THE BROACH IS WHAT BROKE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10684482 ↗
• InjurySep 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DURING A 2ND STAGE KNEE REVISION THE SURGEON REPORTED FRACTURING THE PROXIMAL TIBIA WHEN SEATING THE ATTUNE REVISION TIBIAL BROACH IN THE PROXIMAL TIBIA. THE SURGEON HAD ALREADY PREPARED THE PROXIMAL TIBIA BONE WITH A STEM PILOT/BROACH AND TIB TRAY HOWEVER WHEN HE EXTRACTED THE TRIAL CONSTRUCT (WITH RP ADAPTER AND SYSTEM HANDLE) THE TIB TRAY ROTATION WAS NOT LOCKED AND THEREFORE HE WAS REQUIRED TO RE-SEAT THE STEM TRIAL/BROACH INTO THE PREPARED BONE ENVELOPE AND LOCK OFF HIS RP TRAY ROTATION BEFORE EXTRACTING AND TRANSFERRING THIS TO THE DEFINITIVE IMPLANT/ASSEMBLING. HE COMMENTED THAT WHEN THE REGISTRAR RE-INSERTED THE BROACH INTO THE BONE SHE HIT IT TOO HARD WHICH HE THINKS CAUSED THE FRACTURE. IT WAS WORTH NOTING THAT THE REGISTRAR ALSO HAD GREAT DIFFICULTY EXTRACTING THE TRIAL STEM AND BROACH/TRAY CONSTRUCT ONCE THE ROTATION HAD BEEN LOCKED AND WHEN THE SURGEON TOOK OVER, HE ENDED UP REMOVING THE RP TRIAL TRAY AND ATTACHING THE BROACH HANDLE TO REMOVE THE BROACH (WHICH IS WHEN HE NOTICED THE SMALL FRACTURE IN THE PROX TIB) AND REPEATING THE ABOVE STEPS TO SET THE ROTATION. THE SURGERY CONTINUED AS PLANNED AND HE ADVISED THAT THIS FRACTURE WOULD NOT CHANGE THE OUTCOME OF THE SUR

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10521871 ↗
• 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 8151869 ↗
• InjuryJul 16, 2018Connection Problem; Appropriate Device Problem Term/Code Not Available; Connection Problem; Appropriate Device Problem Term/Code Not Available

  WHILST TIBIAL SLEEVE BROACH IN PLACE THE CONNECTIVITY BETWEEN BROACH AND THE REVISION BROACH HANDLE FAILED (NO STABLE CONNECTION). WITH A SPECIAL INSTRUMENT FROM THE HOSPITAL THE REMOVAL HAPPENED AFTER THE 35 MINUTES SURGICAL DELAY.

  Patient problems: No Code Available

  MAUDE report 7689645 ↗
• MalfunctionJul 3, 2018Break; Break

  IT WAS REPORTED THAT DURING REVISION THE STEM DRILL BROKE OFF THE BROACH. THE STEM TRIAL WAS STUCK IN THE PATIENTS TIBIA AND IT WAS RETRIEVED WITHOUT HAVING ANY CAUSE OR DAMAGE TO PATIENT. ALL PIECES WERE RETRIEVED FROM THE PATIENT. SURGICAL DELAY OF 20-30 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 7658846 ↗