ATTUNE 2544-00-519Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295384403), received between Nov 15, 2017 and Apr 15, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Material Deformation; Mechanical Jam

  DURING A PROCEDURE, THE TWO-PIECE PRODUCT WAS PUT TOGETHER AND IS NOT COMING APART; IT APPEARS THE THREAD OF THE SCREW IS WRAPPED AND NOT LOOSENING. THERE WAS NO PATIENT HARM. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888153 ↗
• MalfunctionJan 23, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA), THE BALANCED SIZER WAS NOT WORKING CORRECTLY. ACCORDING TO THE REPORTER, WHEN TWISTING, THE TOP DOESN'T OPEN UP CORRECTLY AND WAS STIFF. ADDITIONALLY, THE BLACK OVER SIZER DIDN'T SLIDE DOWN OVER THE STEEL ROD. THERE WAS A 15 MINUTE DELAY IN SURGERY REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT CONSEQUENCES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172877 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT BROKEN INSTRUMENT: RESISTANCE IN THE MECHANISM PREVENT NORMAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535568 ↗
• MalfunctionOct 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ATTUNE BALANCING SIZER IS FAULTY. THE SIZING GUIDE IS NOT SLIDING OVER THE DISTRACTOR. IT IS VERY TIGHT AND WILL NOT FUNCTION PROPERLY TO ALLOW FOR SIZING AND BALANCING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403745 ↗
• MalfunctionOct 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ATTUNE BALANCING SIZER IS FAULTY. THE SIZING GUIDE IS NOT SLIDING OVER THE DISTRACTOR. IT IS VERY TIGHT AND WILL NOT FUNCTION PROPERLY TO ALLOW FOR SIZING AND BALANCING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403681 ↗
• MalfunctionJun 5, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TWO PIECE BALANCED SIZER BROKEN. BOTH PARTS WOULD NOT ENGAGE TO BALANCE IN FLEXION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17062146 ↗
• MalfunctionApr 20, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ATTUNE BALANCED SIZER WAS JAMMING A LITTLE WHEN TRYING TO TURN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776152 ↗
• MalfunctionDec 8, 2022Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT BLACK PLASTIC PART OF THE BALANCED SIZER IS VERY STIFF TO SLIDE UP AND DOWN THE REST OF THE BALANCED SIZER. THE METAL RING ON THE TOP OF THE METAL PLASTIC PART IS ABLE TO COME OFF - IT DOESN¿T USUALLY. I¿M NOT SURE IF THIS IS DUE TO THE UPPED OF THE BALANCED SIZER, OR THE BLACK PLASTIC PART BEING TOO SNUG. I HAVE PUT ALL THREE PARTS OF THE BALANCED SIZER ON THIS CST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942417 ↗
• MalfunctionOct 14, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE BALANCED SIZER WAS BINDING AND NOT WORKING CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12634264 ↗
• MalfunctionSep 29, 2021Mechanical Problem; Mechanical Problem

  BALANCED SIZER WOULD NOT TURN PROPERLY. NEEDS TO BE REPLACED. NO DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548084 ↗
• MalfunctionMar 25, 2021Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT TKA SURGERY FOR PRIMARY KNEE OSTEOARTHRITIS WITH ATTUNE SYSTEM. DURING THE SURGERY, THE SURGEON COULD NOT INSERT THE BALANCED SIZER INTO THE DISTRACTOR AT ALL. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGERY WAS DELAYED BY 5 TO 10 MINUTES DUE TO THIS EVENT. AFTER THE SURGERY, THE SALES REP CONFIRMED THERE WAS MULTIPLE DAMAGES ON CONNECTING PART OF THE DEVICES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11568756 ↗
• MalfunctionFeb 17, 2021Mechanical Problem; Material Twisted/Bent

  BALANCED SIZER IS WORN AND NEEDS TO BE REPLACED, THE HANDLE WOULD NOT TURN TO TENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11340152 ↗
• MalfunctionDec 16, 2020Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  ATTUNE BALANCED SIZER IS WORN AND NEEDS REPLACING. SURGEON HAS COMPLAINED MULTIPLE TIMES ABOUT IT. DOES NOT TURN AS IT SHOULD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020417 ↗
• MalfunctionJul 22, 2020Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  PRIOR TO THE CASE, THE SCRUB TECH NOTICED THE BALANCED SIZING TOOL FROM A SET OF LOANER INSTRUMENTS WAS NOT WORKING PROPERLY. NO DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10307799 ↗
• MalfunctionAug 14, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SURGEON USES A COMBINATION OF THE AP MEASURED SIZER AND THE BALANCING SIZER IN HIS TOTAL KNEE ARTHROPLASTY'S. HE FIRST SIZES THE KNEE WITH THE MEASURED SIZER TO GET AN IDEA OF WHAT SIZE HE'S LOOKING AT, AND THEN USES THE BALANCED SIZER TO CONFIRM. AFTER DR. FINISHED USING THE BALANCED SIZER COMPLETELY AND TOOK IT OFF, HE NOTICED THAT THE 2 PIECES THAT MAKE UP THE ATTUNE BALANCED SIZER DISTRACTOR ROD SEEMED TO BE CROSS-THREADED AND COULD NOT BE LOOSENED BACK UP. THIS DID NOT DELAY THE CASE IN ANY WAY AS SURGEON WAS ALREADY FINISHING USING IT AND CONTINUED TO PROCEED TO THE NEXT STEP. REPLACEMENTS ARE NEEDED TO COMPLETE THE FEMORAL SIZING AND FINISHING TRAY. UPON EXAMINATION, THE INTERNAL ROD COMPONENT OF THE DEVICE WAS FOUND TO BE JAMMED/FROZEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8894432 ↗
• MalfunctionDec 21, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHILE TRYING TO SIZE FEMUR, BALANCED SIZER FROZE UP AND COULD NOT BE TURNED WITH SURGEONS GRIP, BALANCED SIZER REMOVED AND USED OTHER FEMUR SIZER. DURING IMPACTION OF TIBIAL COMPONENT THE RED TAB ON IMPACTION HANDLE BROKE OFF FALLING ON TABLE, AREA SEARCHED NOTHING IN WOUND. USED DIFFERENT HANDLE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189804 ↗
• MalfunctionDec 21, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHILE TRYING TO SIZE FEMUR, BALANCED SIZER FROZE UP AND COULD NOT BE TURNED WITH SURGEONS GRIP, BALANCED SIZER REMOVED AND USED OTHER FEMUR SIZER. DURING IMPACTION OF TIBIAL COMPONENT THE RED TAB ON IMPACTION HANDLE BROKE OFF FALLING ON TABLE, AREA SEARCHED NOTHING IN WOUND. USED DIFFERENT HANDLE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189786 ↗
• MalfunctionOct 12, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE BALANCE SIZER THREADS DO NOT WORK PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7960036 ↗
• MalfunctionAug 24, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BALANCED SIZER WOULDN'T SLIDE PROPERLY WHEN THE DIAL WAS TURNED. SURGEON ASKED THAT IT BE REPLACED FOR A NEW ONE.

  Patient problems: No Code Available

  MAUDE report 7813410 ↗
• MalfunctionAug 21, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT SCRUB DISCOVERED PRIOR TO START OF CASE THAT THE BALANCED SIZING GUIDE PART # 254400519 WOULD NOT FUNCTION PROPERLY. IT SEEMS TO BE STICKING AND WILL NOT FULLY ENGAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801575 ↗
• MalfunctionAug 21, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT SCRUB DISCOVERED PRIOR TO START OF CASE THAT THE BALANCED SIZING GUIDE PART # 254400519 WOULD NOT FUNCTION PROPERLY. IT SEEMS TO BE STICKING AND WILL NOT FULLY ENGAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801544 ↗
• MalfunctionMay 22, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE BALANCED SIZER CONSTRUCT WAS VERY DIFFICULT TO TURN. THE CASE WAS NOT AFFECTED WITH THE ISSUE. IT FEELS LIKE METAL RUBBING TOGETHER MAKING IT DIFFICULT TO TURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7532788 ↗
• MalfunctionMay 22, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE BALANCED SIZER CONSTRUCT WAS VERY DIFFICULT TO TURN. THE CASE WAS NOT AFFECTED WITH THE ISSUE. IT FEELS LIKE METAL RUBBING TOGETHER MAKING IT DIFFICULT TO TURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7532785 ↗
• MalfunctionNov 15, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE TENSIONER IS COLDWELDED TOGETHER.

  Patient problems: No Information

  MAUDE report 7033924 ↗