ATTUNE 2546-00-422Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295440352), received between Nov 9, 2017 and Sep 14, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50764133 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED DURING THE WORKSHOPS, THERE WERE MANY DIFFICULTIES IN MATING THE FB TEST TIBIAL BASES WITH THE LL/MR WEDGE TESTS. FOR EXAMPLE, IN SOME CASES IT IS IMPOSSIBLE TO GET THE WEDGE TO BE 100% FIXED TO THE TIBIAL TEST, LEAVING IT SLIGHTLY LOOSE WITH A LIGHT BETWEEN BOTH COMPONENTS. IN OTHER CASES, THE WEDGE SCREW WAS FUSED TO THE TIBIAL BASE, MAKING IT IMPOSSIBLE TO DISENGAGE THEM. AT FIRST, WE SUSPECTED THAT SOME OF THE PARTICIPANTS WERE BEING "ROUGH" WITH THE MATERIALS. HOWEVER, WE DID THE TEST, AND EVEN THOUGH WE WERE VERY CAREFUL, THE SAME THING HAPPENED TO US. ON THE OTHER HAND, THE 2 PIECES (COD 254600422), BOTH FROM THE SAME BATCH, BROKE WHEN THE DECOUPLING OF THE DEFINITIVE IMPLANTS WAS CARRIED OUT. IN BOTH CASES, THE RUPTURE OCCURRED AFTER COUPLING AND UNCOUPLING APPROXIMATELY 10 TIMES. THE USE OF THE DEVICE WAS BEING CORRECT. THE INSTRUMENTS ASSOCIATED WITH ATTUNE REVISION WERE USED. THE REALITY IS THAT DUE TO THE SIZE OF THE PLASTIC BONES, IT WAS WORKED WITH TIBIAL BASES 4 AND 5. I TRIED THE 6 AND HAD PROBLEMS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24969520 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT DURING WORKSHOPS, THERE WERE DIFFICULTIES IN MATING THE FB TEST TIBIAL BASES WITH THE LL/MR WEDGE TESTS. ACCORDING TO THE REPORT, IN SOME CASES IT WAS IMPOSSIBLE TO GET THE WEDGE TO BE 100% FIXED TO THE TIBIAL TEST, LEAVING IT SLIGHTLY LOOSE WITH A LIGHT BETWEEN BOTH COMPONENTS. IN OTHER CASES, THE WEDGE SCREW WAS FUSED TO THE TIBIAL BASE, MAKING IT IMPOSSIBLE TO DISENGAGE. IT WAS REPORTED THAT IT WAS SUSPECTED THAT SOME OF THE PARTICIPANTS WERE BEING "ROUGH" WITH THE MATERIALS. HOWEVER, AFTER TESTING, AND EVEN THOUGH THE USER WAS CAREFUL, THE SAME THING HAPPENED. ADDITIONALLY, IT WAS REPORTED THAT THE ATTUNE KNEE SYSTEM REVISION ASSEMBLY OFFSET STABILIZER X2, BROKE WHEN THE DECOUPLING OF THE DEFINITIVE IMPLANTS WAS CARRIED OUT. IN BOTH CASES, THE DEVICE BROKE AFTER COUPLING AND UNCOUPLING APPROXIMATELY 10 TIMES. IT WAS FURTHER NOTED THAT THE USE OF THE DEVICE WAS CORRECT. IT WAS REPORTED THAT DUE TO THE SIZE OF THE PLASTIC BONES, THE DEVICE WORKED WITH TIBIAL BASES 4 AND 5. THE USER HAD PROBLEMS WITH USING THE 6. HOWEVER, IF NECESSARY, IT COULD BE USED. WAS THERE ANY HARM TO THE REPORTED PATIENT OR USER? NO. WAS THERE A SIGNIFICANT DELAY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957121 ↗
• MalfunctionNov 13, 2025Unintended Movement; Unintended Movement

  DURING USE OF THE STABILIZER, THERE IS A KNOB (HIGHLIGHTED IN RED IN THE PHOTO). THIS KNOB IS USED TO TIGHTEN AND HOLD THE FINAL PROSTHESIS IN PLACE FOR ASSEMBLY. THIS KNOB IS VERY TIGHT AND DIFFICULT TO LOOSEN OR TIGHTEN, HINDERING ASSEMBLY. TO DO SO, IT WAS NECESSARY TO USE A WRENCH AND APPLY CONSIDERABLE FORCE. TIGHTENING AND LOOSENING IT SHOULD BE DONE GENTLY, USING ONLY THE FINGERS, TO ACHIEVE THIS ROTATION. THIS KNOB MUST BE REPLACED BECAUSE EVENTUALLY IT WILL STOP TURNING, OR THE INTERNAL THREADS WILL BREAK DUE TO EXCESSIVE FORCE, PREVENTING PROPER IMPLANT ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544271 ↗
• MalfunctionNov 10, 2025Break; Break

  DURING THE PROCEDURE, IT WAS EVIDENT THAT THE ASSEMBLY WRENCH WAS MISSING A SCREW. IT ALSO OCCURRED THAT WHILE WE WERE HOLDING THE TIBIA TO TIGHTEN THE STEM, THE OFFSET ASSEMBLY STABILIZER BROKE, PREVENTING THE SURGICAL TEAM FROM ASSEMBLING THE OFFSET. THEY ATTEMPTED TO ASSEMBLE IT WITH ONE PERSON HOLDING IT, RESPECTING THE OFFSET DIRECTION, BUT THIS WAS NOT POSSIBLE BECAUSE IT ROTATED. TO RESOLVE THIS, THE DOCTOR, AFTER SEVERAL ATTEMPTS, DECIDED TO USE MORE REAMER AND BYPASS THE OFFSET, THEN TIGHTEN IT MANUALLY OUTSIDE THE ASSEMBLY. THIS ALLOWED FOR SUCCESSFUL COMPLETION OF THE SURGERY WITHOUT AFFECTING THE PATIENT. IT CAUSED A DELAY OF APPROXIMATELY THIRTY MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 23511109 ↗
• MalfunctionNov 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIECE WOULD NOT THREAD. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472610 ↗
• MalfunctionJun 25, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SCREW IS STUCK AND WONT MOVE. THERE IS NO ALLEGATIONS AGAINST THE SCREW. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329456 ↗
• MalfunctionDec 31, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE ATTUNE OFFSET STABILIZER WAS BROKEN AGAIN DURING A PROCEDURE. THE INSTRUMENT WAS TORQUED BY HAND, CAUSING THE INSTRUMENT TO CROSS THREAD. THIS INSTRUMENT WAS NEEDED DURING THE OPERATION AND THEY HAD TO TRY AND FIND ALTERNATIVES DURING THE OPERATION AS A RESULT OF THIS BREAKAGE. THE OPERATION WAS DELAYED AS A RESULT OF THIS, BUT ASIDE FROM THAT NO PATIENT OUTCOMES WERE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048046 ↗
• MalfunctionDec 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIGHTENING KNOB IS CROSS THREADED. IT DIDNT HAPPEN IN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 20849231 ↗
• MalfunctionJun 6, 2024Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE ATTUNE REVISION OFFSET STABILIZER HANDLE WOULDN'T LOOSEN TO FIT AROUND ATTUNE REVISION TIBIAL SLEEVE FOR IMPLANT ASSEMBLY. APPEARS THAT THREAD ON THE BOLT IS POTENTIALLY CROSS THREADED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475651 ↗
• MalfunctionJan 30, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT WHILE TIGHTENING THE OFFSET STABILIZER, THE THREADED END WAS CROSS-THREADED AND WOULD NOT LOOSEN. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610851 ↗
• MalfunctionMay 5, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT UPON INSPECTING INSTRUMENTS THAT WERE RETURNED, THE TIGHTENING BOLT OF ATTUNE REV ASMBLY OFST STABLIZR IS CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876327 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE BOLT THREAD FOR STABILISING THE OFFSET ADAPTER DURING ASSEMBLY OF IMPLANT WAS STUCK SO UNABLE TO HOLD POSITION OF OFFSET ADAPTER WHEN TIGHTENING. DELAYED SURGICAL TIME BY 30 MINS. OPERATION - ATTUNE REVISION KNEE - OFFSET FEMORAL STEM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590055 ↗
• MalfunctionOct 14, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT OFFSET ATTUNE REVISION HANDLE, WAS FOUND TO BE BROKEN TODAY DURING SURGERY RESULTING IN A 15 MINUTE DELAY. NO ADVERSE EFFECTS ON PATIENT. THIS INSTRUMENT NEEDS TO BE REPLACED AS A MATTER OF URGENCY AS OUR SET IS NOW INCOMPLETE. NO UNTOWARD EFFECTS ON PATIENT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606003 ↗
• MalfunctionJun 22, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY TODAY THE BELOW INSTRUMENT WAS FOUND TO BE NOT WORKING CORRECTLY DUE TO A STUCK LOCKING NUT. NO DELAY WAS CAUSED TO SURGERY. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775074 ↗
• MalfunctionJan 21, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ONE OF THE INSTRUMENTS ON THE ATTUNE REVISION SET HAS BEEN CROSS THREADED AND IS NO LONGER USEABLE. THERE WAS NO SURGERY AT THE TIME AND NO DELAYS HOWEVER THE INSTRUMENT WOULD NOT BE ABLE TO BE USED FOR PART OF ITS PURPOSE IF AN OFFSET STEM WAS BEING UTILISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314075 ↗
• MalfunctionSep 24, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  OFFSET STABILIZER WOULD NOT LOCK. THE KNOB AT THE END OF THE ARM IS CROSS THREADED OR JAMMED. IT WOULD NOT BUDGE FOR US AND DID NOT ALLOW US TO LOCK ONTO THE OFFSET LOCKING BOLT WHEN TORQUING IT TO THE FEMORAL COMPONENT. THIS JEOPARDIZED OUR CASE AS IT MADE IT EXTREMELY DIFFICULT TO PROPERLY HOLD OUR OFFSET ROTATION AND PROPERLY TORQUE THE OFFSET BOLT. THIS ISSUE ADDED 30 MINUTES OF OPERATIVE TIME.

  Patient problems: Insufficient Information

  MAUDE report 12527396 ↗
• MalfunctionSep 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ATTUNE REVISION OFFSET STABILIZATION ARM WOULD NOT TIGHTEN AS IT WAS SUPPOSED TO AROUND THE OFFSET IMPLANT. THIS CAUSED A PROBLEM WHEN TRYING TO TIGHTEN THE OFFSET NUT, SO WE HAD TO FIND ALTERNATE MEANS TO ACCOMPLISH THIS, WHICH DELAYED THE CASE BY ABOUT 15 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 12446619 ↗
• MalfunctionJul 29, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SCREW IS STRIPPED ON THE OFFSET STABILIZER FOR ATTUNE REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246489 ↗
• MalfunctionJun 7, 2021Break; Mechanical Jam; Break; Mechanical Jam

  THE OFFSET STABILIZER HAS BROKEN INTO TWO PIECES. NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11945943 ↗
• MalfunctionMar 24, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE OFF SETT STABILIZER ARM DOESN¿T UNSCREW . THE SCREW IS CROSS THREADED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563285 ↗
• MalfunctionFeb 19, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN ATTEMPTING TO ATTACH TO OFFSET, ADAPTER, IT WAS CLEAR THE THREAD/BOLT ON SIDE WAS CROSS THREADED AND WOULD NOT ENGAGE/RELEASE.SURGICAL DELAY OF 30 MINUTES WAS NOTED.

  Patient problems: Insufficient Information

  MAUDE report 11352501 ↗
• MalfunctionDec 10, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10983676 ↗
• MalfunctionNov 24, 2020Break; Structural Problem; Break; Structural Problem

  IT WAS REPORTED THAT THE ASSEMBLY TOOL BOLT THAT TIGHTENS THE LOCKING BOLT IS BROKEN, AND NO LONGER LOCKS INTO THE OFFSET STABILIZER ARM. IT WAS ALSO REPORTED THAT THE FEMORAL IMPACTOR WAS BROKEN UPON IMPACTION OF THE FEMUR. IT IS STILL IN ONE PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10890788 ↗
• MalfunctionSep 24, 2020Mechanical Jam; Mechanical Jam

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS A 15 MINUTE SURGICAL DELAY.

  Patient problems: No Code Available

  MAUDE report 10580681 ↗