ATTUNE 2506-10-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295435877), received between Apr 1, 2021 and Apr 23, 2026 — classified as 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Device-Device Incompatibility; Unintended Movement

  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 24969182 ↗
• MalfunctionApr 22, 2026Device-Device Incompatibility; Unintended Movement

  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 24957147 ↗
• MalfunctionAug 29, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A WORKSHOP, IT WAS NOT POSSIBLE TO PROPERLY FIX THE THE TRIAL AUGMENTS IN THE TRIAL TIBIAE. IT SEEMS THAT SOMETHING IS WRONG WITH THE TREADS OF THE TRIAL. THEY ARE SOMEHOW COLD WELDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22921974 ↗
• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT THE CENTRAL SCREW HEAD BROKE OFF. SURGERY WAS NOT DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED BUT WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241909 ↗
• MalfunctionApr 1, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT AS PER THE ATTACHED PHOTO, THE DEVICE BROKE INTO 3 PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11605036 ↗