ATTUNE 2544-00-018Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10603295434054), received between Oct 30, 2018 and Sep 11, 2026 — classified as 71 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (21 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 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Device-Device Incompatibility

  It was reported that the set screw not functioning properly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50738077 ↗
• MalfunctionSep 10, 2026Break

  It was reported that tibial jig has broken retainer clip.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716675 ↗
• MalfunctionMay 19, 2026Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VIEWFINDER ADJUSTMENT WHEEL WAS SEIZED, AND IT WAS IMPOSSIBLE TO TIGHTEN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25223005 ↗
• MalfunctionApr 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT ATTUNE EM TIBIAL PROX UPROD CAME APART AND WAS FOUND UNATTACHED DURING BOTH STERILE PROCESSING AND FIELD INSPECTION. THE EVENT DID NOT INVOLVE ANY PATIENT IMPACT OR REQUIRE MEDICAL INTERVENTION, AND THERE WERE NO OBSERVABLE CLINICAL SYMPTOMS OR CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886306 ↗
• MalfunctionMar 26, 2026Mechanical Jam

  IT WAS REPORTED THAT THE SCREW SEEMED TO BE STUCK IN THE TIBIAL JIG. IT WAS NOTED THAT THE SCREW WAS HALF WAY IN THE HOLE. IT WAS FURTHER REPORTED THAT THE SURGEON TRIED TO LOOSEN BUT WAS CAUSING FURTHER DAMAGE TO JIG. NO PATIENT WAS HARMED, ALTERNATIVE TRAY WAS OPEN AND USED TO COMPLETE THE PROCEDURE. NOTHING WAS BROKEN, NO LOOSE PARTS, NOTHING LEFT INSIDE THE PATIENT AND NO RETURN TO THEATRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698363 ↗
• MalfunctionMar 23, 2026Device-Device Incompatibility

  IT WAS REPORTED THE SCRUB TEAM REPORTED THAT THE JIG¿S PROXIMAL LOCKING MECHANISM FAILS TO ENGAGE THE TIBIAL CUTTING BLOCK SECURELY, LEAVING IT LOOSE INTRA OPERATIVELY; NO ISSUES CAUSED TO THE PROCEDURE AND PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661326 ↗
• MalfunctionMar 17, 2026Mechanical Jam

  ITEM ISSUES FOUND DURING ROUTINE TRAY INSPECTION. SHIM BROKEN IN TWO PIECES. UPROD NO LONGER FUNCTIONS AS DESIGNED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619956 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT THE TIBIAL JIG WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401976 ↗
• MalfunctionJan 20, 2026Break

  IT WAS REPORTED THAT THE FB TIBIAL IMPACTOR AND EXTRA-MEDULLARY TIBIAL PROXIMAL UPROD BROKE UPON IMPACTION. THE EVENT DID NOT OCCUR DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120601 ↗
• MalfunctionJan 16, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE CUTTING BLOCK ATTACHMENT AT THE TOP WILL NOT STAY CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094050 ↗
• MalfunctionDec 24, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT BUTTON FOR CUTTING BLOCK WAS JAMMED. PROBABLY DUE TO OVERUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888938 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TIBIA CUTTING GUIDE UPROD KNOB BECAME FULLY UNTHREADED AND WOULD NOT FULLY ENGAGE INTO CLAMP HOLDER. IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. NO FURTHER INFO AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646771 ↗
• MalfunctionNov 5, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE BOTTOM RED KNOB OF THE TIBIAL PROXIMAL UPROD CAME LOOSE AND WAS UNABLE TO GO BACK IN AND TIGHTEN. IT WAS FOUND BEFORE INCISION. THERE WAS NO PATIENT INVOLVEMENT AND NO DELAYS AND NO INJURY. NO MORE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476010 ↗
• MalfunctionOct 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RED SCREW-BUTTON DOESN'T CONNECT WITH THE ROD ANYMORE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390387 ↗
• MalfunctionJul 9, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE HEIGHT ADJUSTMENT KNOB DID NOT THREAD CORRECTLY AND WOULD NOT STAY IN PLACE AND LOCK HEIGHT. IT WAS NOTICED NOT DURING SURGERY. THERE WAS NO DELAY OF SURGERY, NO ISSUE TO PATIENT, NO ISSUE TO SURGEON. REPLACEMENT IS NEEDED. THE CUSTOMER REPORTED THAT THEY WOULD RETURN THE BROKEN PIECE WHEN ABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456779 ↗
• MalfunctionJul 8, 2025Mechanical Jam; Mechanical Jam

  IT BEEN REPORTED THAT DURING THE SURGICAL PREPARATION, IT WAS DISCOVERED THAT THE ALIGNMENT ROD WAS JAMMED. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436380 ↗
• MalfunctionJun 25, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPRING ON THE SPACER BLOCK WHICH IS USED TO RETAIN THE SHIMS POPPED OFF AND STRETCHED OUT, THE ATTUNE MEASURED SIZER NO LONGER ENGAGES AT THE PROPER EXTERNAL ROTATION INCREMENTS, AND THE PROXIMAL TIBIAL CUT GUIDE KNOB TO ADJUST THE RESECTION HEIGHT POPPED OFF AND DOES NOT THREAD BACK ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332950 ↗
• MalfunctionJun 25, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING SETUP PRIOR TO THE CASE, THE SCRUB NURSE WAS UNABLE TO TURN THE RED ADJUSTMENT DIAL ON THE PROXIMAL UPROD SO THE TIBIAL JIG COULD NOT BE ASSEMBLED. ANOTHER SET WAS OPENED AND THE CASE PROCEEDED AS NORMAL. WHEN THE INSTRUMENT WAS EXAMINED, THE DIAL SEEMED TO BE JAMMED. THE INSTRUMENT WAS HIT AGAINST THE SIDE OF THE INSTRUMENT TRAY AND THE DIAL THEN LOOSENED AND COULD BE TURNED BUT DID NOT TURN SMOOTHLY, SO IT IS NOT IN A CONDITION TO BE USED FOR SURGERY AND WILL NEED TO BE REPLACED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329290 ↗
• MalfunctionJun 12, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE ATTUNE® PROXIMAL EXTRA-MEDULLARY ALIGNMENT ROD NO LONGER HOLDS THE TIBIAL CUTTING BLOCKS. THE DEVICE DOES NOT ENGAGE PROPERLY IN THE CUTTING BLOCK. NO PATIENT WAS HARMED. THE BLOCK WAS JAMMED, ONLY IN ALIGNMENT. THIS WAS DISCOVERED DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192598 ↗
• MalfunctionMay 5, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DIAL DID NOT TIGHTEN DOWN. THE DEVICE FELL APART WHEN LOOSENED ALL THE WAY. THE ISSUE DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959110 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED ONE INSTRUMENT IN THE SHORT-TERM-LOANER-KIT (ORTHOKIT) SHOWED WEAR. THE LAST LOAN SYSTEM "ATTUNES" DELIVERED COMES WITH AN INSTRUMENT THAT IS DEFECTIVE. THE PLASTIC ABRASION ON THE ADJUSTMENT LEVER MAKES IT IMPOSSIBLE TO USE IT. THERE WAS NO SURGICAL DELAY. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880932 ↗
• MalfunctionMar 26, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TIBIAL JIG WAS DAMAGED. THE RED, CIRCULAR PART WITH THREADS WOULD NOT TIGHTEN PROPERLY; THE THREADS STRIPPED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698441 ↗
• MalfunctionMar 13, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE ATTUNE ANKLE CLAMP IS VERY STIFF AND OFTEN GETS STUCK, THUS MAKING IT UNUSABLE FOR SURGERY. THERE WAS NO EFFECT TO PATIENT AND NO SEVERE DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593254 ↗
• MalfunctionJan 15, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY, THE TIBIA ALIGNMENT INSTRUMENT WAS DEFECTIVE. THE RED SCREW SEIZED. THERE WAS NO SURGICAL DELAY.

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

  MAUDE report 21159208 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT THE RED KNOB OF THE INSTRUMENT BROKE OFF WHILE TIGHTENING. UNKNOWN SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21141063 ↗