ATTUNE 2546-00-401Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295438700), received between Jan 23, 2019 and Oct 29, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  I HAVE BEEN INFORMED THAT THE INSTRUMENT BROKE DURING KNEE SURGERY. THE HOOK HAS BROKEN AND WON¿T CLIP ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412831 ↗
• MalfunctionJul 24, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ITEMS FROM THE ATTUNE REVISION SET WERE REPORTED FOR AN UNKNOWN ALLEGATION.

  Patient problems: Insufficient Information

  MAUDE report 22588026 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT LIP BROKE OFF AND CAN NO LONGER EXTRACT.

  Patient problems: Insufficient Information

  MAUDE report 21642235 ↗
• InjurySep 11, 2020Device Slipped; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device Slipped; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  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 10521867 ↗
• MalfunctionOct 14, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH HANDLE DOES NOT STAY CONNECTED TO FEMORAL BROACHES AND THE TIBIA ADAPTOR TO REMOVE THE TRIAL TIBIA TRAYS DISCONNECTS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187329 ↗
• MalfunctionJan 23, 2019Connection Problem; Connection Problem

  THE EXTRACTOR INSTRUMENT WON¿T STAY CONNECTED TO THE HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270949 ↗