ATTUNE 2544-00-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295421191), received between Feb 11, 2019 and Oct 31, 2024 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT'S HOLE IS BURRED/SHARP METAL.

  Patient problems: Insufficient Information

  MAUDE report 20576845 ↗
• MalfunctionMar 8, 2024Device-Device Incompatibility; Difficult to Advance; Naturally Worn; Device-Device Incompatibility; Difficult to Advance; Naturally Worn

  IT WAS REPORTED THAT THE ATTUNE RIGHT TIBIAL CUTTING BLOCK HAS BECOME WORN IN THE SLOT WHERE THE STYLUS WILL NOT STAY SEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864841 ↗
• MalfunctionJan 18, 2024Material Deformation; Material Deformation

  DURING REGULAR MDRD INSPECTION A METAL BURR WAS FOUND ON THE DEVICE IN QUESTION AND IT WAS REMOVED FROM USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533838 ↗
• MalfunctionDec 20, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PIN HOLE HAS BURR IN IT AND IT PREVENT PIN FROM BEING ADVANCED THROUGH THE BLOCK. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18366247 ↗
• MalfunctionJun 6, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PIN GOT JAMMED IN RIGHT 0 DEGREE CUTTING BLOCK CAUSING PIN TO SNAP AT THE TIP. BOTH PARTS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071133 ↗
• MalfunctionJun 16, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE METAL POST WHICH SLOTS INTO THE BROACH HANDLE IS DAMAGED AND WAS DISCOVERED DURING RANDOM SET INSPECTIONS. NONE OF THE BROKEN INSTRUMENTS HAVE CAUSED ANY ISSUED WITH PATIENTS OR SURGERY AS THEY WERE IDENTIFIED PRIOR TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712995 ↗
• MalfunctionApr 26, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF SOME ATTUNE CONSIGNMENT INSTRUMENTATION TRAYS, BY STERILE PROCESSING DEPARTMENT PERSONNEL, IT WAS DISCOVERED THAT THREE OF THE INSTRUMENTS WERE DAMAGED. TWO ATTUNE FEMORAL IMPACTOR WERE CRACKED AND THE SAW CAPTURE OF A TIBIAL CUTTING GUIDE HAD BEEN CUT INTO BY A SAW BLADE. BOTH CRACKS EXTENDED FROM THE CENTRAL PORTION TO DISTAL PORTION OF THE TWO IMPACTORS. THE CUT IN THE TIBIAL CUTTING GUIDE IN LOCATED IN THE LATERAL EDGE OF SAW CAPTURE. REPLACEMENT INSTRUMENTS ARE NEEDED TO COMPLETE THE CONSIGNMENT TRAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14208577 ↗
• MalfunctionMar 17, 2022Material Deformation; Material Deformation

  TRIAL POST IS BROKEN. THERE IS A PIECE OF METAL STICKING OUT OF THE LEFT TIBIA CUTTING BLOCK. THERE IS A PIECE OF METAL STICKING OUT OF THE RIGHT TIBIA CUTTING BLOCK AS WELL, BUT IT WAS DISCOVERED AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13802192 ↗
• MalfunctionJul 20, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY WITH THE BLOCK AND PIN IN QUESTION. AFTER THE OSTEOTOMY, THE SURGEON TRIED TO REMOVE THE BLOCK FROM THE PATIENT, BUT THE DIAGONAL PIN DID NOT COME OUT. TWO FIXATION PINS WERE REMOVED, AND BOTH ONE DIAGONAL PIN AND THE BLOCK WERE REMOVED FROM THE PATIENT. AFTER THE OPERATION, AN ATTEMPT WAS MADE TO REMOVE THE DIAGONAL PIN FROM THE BLOCK, BUT IT WAS IMPOSSIBLE BECAUSE THE PIN HAD BEEN STUCK INTO THE BLOCK. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12199790 ↗
• MalfunctionApr 5, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE THREADED PIN GOT STUCK IN CROSS PIN HOLE AND COULD NOT BE EXTRACTED. NOTHING WAS RETAINED IN PATIENT AND NO DELAY. THIS IS ALL INFO I HAVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615625 ↗
• MalfunctionMar 24, 2021Scratched Material; Scratched Material

  SCUFFED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11562886 ↗
• MalfunctionMar 15, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PIN WOULD NOT PASS FREELY THROUGH ONE OF THE PIN HOLES OF THE ATTUNE RIGHT TIBIAL BLOCK. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11488570 ↗
• MalfunctionMar 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A PIN IS INCARCERATED IN THE TIBIA CUT BLOCK. NO PATIENT HARM AND NO SURGICAL DELAY REPORTED. ALSO REPORTED, THE METAL RING ON ONE OF THE 9X5MM SHIMS LOOK LOOSE WHILE ANOTHER 9X6MM SHIM HAS A HAIRLINE CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484646 ↗
• MalfunctionFeb 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DURING AN ATTUNE PS FB SURGERY, POST PROXIMAL TIBIA RESECTION THROUGH THE "ATTUNE 0 DEG RIGHT CUT BLOCK", A NEW SINGLE USE "LOCKING PIN" WAS JAMMED IN THE "CUT BLOCK" WITH NO OPTION OF REMOVAL. THE SURGEON COMPLAINED THAT THIS HAS HAPPENED BEFORE AND EVEN THOUGH HE MANAGED TO DISLODGE THE "CUT BLOCK" WITH NO FRAGMENTS LEFT IN THE PATIENT, NO EXTRA SURGERY TIME LOST OR ANY DAMAGE DONE TO THE PATIENT, THE SURGEON REQUESTED THE ITEMS BE INSPECTED FURTHER. THE SURGERY WENT ON WITH NO ADDITIONAL ISSUES AND TO A SATISFACTORY FINAL OUTCOME AS FAR AS THE SURGEON WAS CONCERNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282470 ↗
• MalfunctionDec 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PIN BECAME STUCK IN PIN HOLE OF TIBIA CUTTING BLOCK. COULD NOT BE REMOVED BY ANY OF SEVERAL ATTEMPTED MEANS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11056733 ↗
• MalfunctionSep 23, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  A STEINMANN PIN WAS UNABLE TO BE EXTRACTED FROM THE TIBIAL CUT BLOCK AFTER IT WAS USED DURING A PRIMARY TOTAL KNEE REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10575520 ↗
• MalfunctionAug 20, 2020Material Deformation; Material Deformation

  JAGGED EDGE ON TIBIAL CUTTING BLOCK CUT SURGEON'S GLOVE. GLOVES CHANGED, NO FURTHER HARM OR DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10432159 ↗
• MalfunctionAug 11, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A THREADED PIN WAS INCARCERATED IN AN ATTUNE TIBIA CUT BLOCK AND BROKEN INTO TWO PIECES. ONE PIECE STAYED INSIDE PIN DRIVER AND SECOND SIDE WAS STUCK IN CUT BLOCK. SLIGHT DELAY TO GET BLOCK OFF PATIENT BY CUTTING PIN AND UNSCREWING MANUALLY. NO PATIENT HARM.

  Patient problems: No Code Available

  MAUDE report 10390705 ↗
• MalfunctionJul 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ATTUNE 0 DEG RIGHT CUT BLOCK HAS A BURR ON THE END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10324197 ↗
• MalfunctionJun 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THE CONSTRUCT OF THE THREE ASSEMBLED INSTRUMENTS IS WOBBELING. NO SURGERY DELAY, NO PART REMAINING IN PATIENT, NO SURGERY DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8665121 ↗
• MalfunctionFeb 11, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PRODUCT WAS WORN AND NEEDS TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8325959 ↗