ATTUNE 2511-11-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295435754), received between Dec 11, 2018 and Sep 17, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Break; Break

  WHILE BROACHING FOR THE ATTUNE REVISION TIBIAL SLEEVE, THE 12X60 SHEARED OFF THE 29MM TIBIAL SLEEVE. MANAGED TO FISH THE STEM OUT WITH A LONG GRASPER SO VERY LITTLE DELAY TO THE SURGERY AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072974 ↗
• MalfunctionJun 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A BROKEN STEM AT THE THREADS WHERE IT ATTACHES TO THE TIBIAL BROACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22229289 ↗
• MalfunctionApr 28, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE 29 TIBIAL METAPHYSEAL SLEEVE FROM THE TIBIA THE BROACH HANDLE KEPT SLIPPING OFF INDICATING THE ATTACHMENT WAS STRIPPED. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16835208 ↗
• MalfunctionAug 2, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE STEM TRIAL BROKE. THE THREADED PORTION JUST ABOVE THE STEM TRIAL SNAPPED. THE THREADED BROKEN PIECE REMAINED IN THE 29 SLEEVE. ALL PIECES ACCOUNTED FOR AND THE CASE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15152321 ↗
• MalfunctionJun 20, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE STEM PILOT WILL NOT SCREW ONTO 29MM ATTUNE REV TIBIAL BROACH, TIBIAL BROACH LOOKS LIKE IT WAS DAMAGED FROM A PREVIOUS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14742854 ↗
• MalfunctionJun 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH COULD NOT BE ATTACHED TO A STEM TRIAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675574 ↗
• MalfunctionJun 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH HANDLES WOULD NOT GRAB BROACH TO PULL IT OUT. HAD TO BAIL TO THREADED BROACH REMOVER. SPRING IN HANDLE SEEMS WEAK OR LATCH MECHANISM DOESN'T WORK PROPERLY. HAS HAPPENED IN MULTIPLE OTHER CASES AS WELL. THERE IS A 8 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630888 ↗
• MalfunctionDec 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 29 BROACH IN THE ATTUNE REVISION RP AND BROACH TRAY WOULD NOT LET THE STEM TRIAL SCREW DOWN ALL THE WAY. IT DID NOT AFFECT SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094949 ↗
• MalfunctionFeb 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH WILL NOT RELEASE FROM THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11303496 ↗
• MalfunctionNov 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL BROACH DOESN¿T LATCH ONTO HANDLE. NO PIECES, ALL WERE RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10863135 ↗
• MalfunctionOct 7, 2020Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE 29MM ATTUNE TIBIAL BROACH WOULD NOT ENGAGE INSERTED HANDLE. LIP WHERE HANDLE ENGAGES IS WORN DOWN. SURGICAL DELAY OF 10 MINUTES WAS NOTED.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10643418 ↗
• MalfunctionNov 27, 2019Material Deformation; Material Twisted/Bent; Naturally Worn; Material Deformation; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE RP IMPLANT IMPACTOR WAS CRACKED UPON IMPLANTATION OF FINAL TIBIAL IMPLANT, NO PIECES BROKEN OFF. 29MM TIBIAL SLEEVE BROACH DISTAL END WAS DAMAGED AND STEM TRIAL NO LONGER ABLE TO THREAD ON TO THE BROACH. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9383601 ↗
• MalfunctionFeb 19, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE ATTUNE REVISION 29MM SLEEVE BROACH GOT STUCK IN THE TIBIA. BOTH BROACH HANDLE KEPT RELEASING ON EXTRACTION. THESMALL 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 8349617 ↗
• 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 8151925 ↗