ATTUNE 2544-00-517Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295327554), received between Jan 16, 2018 and Jan 23, 2026 — classified as 17 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Device-Device Incompatibility; Mechanical Jam

  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 24172875 ↗
• MalfunctionDec 9, 2025Mechanical Jam; Mechanical Jam

  ATTUNE BALANCED FEMORAL SIZER: ISSUE IS THE STYLES NOT WORKING NO PATIENT AFFECTED OR SURGERY DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23761088 ↗
• 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 23403677 ↗
• MalfunctionOct 17, 2024Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT WHEN FINISHED MEASURING THE FEMUR WITH THE METER, IT WAS EVIDENT THAT THE INNER SILVER ROD OF THE METER WAS LOOSE, BUT IT WAS STILL POSSIBLE TO PERFORM THE MEASUREMENT THAT WAS NEEDED. AT THE END, IT WAS IDENTIFIED THAT THE INTERNAL ROD WAS PARTED, BECAUSE IT WAS NOT AS NORMALLY SHOULD BE. THERE WERE NO ISSUES WITH THE SPECIALIST, NOR AFFECTATIONS TO THE PATIENT, NOR ALTERATIONS IN THE SURGICAL TIMES AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20469849 ↗
• MalfunctionDec 8, 2022Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT THE BLACK PLASTIC PART OF THE BALANCED SIZER IS VERY STIFF TO SLIDE UP AND DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942385 ↗
• MalfunctionDec 3, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THE BOTTOM PART OF THE ATTUNE BALANCED FEMORAL SIZER HAS BENT AND WILL NOT SCREW TO ASSEMBLE WITH THE TOP PART OF THE SIZER. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923832 ↗
• MalfunctionJul 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE STYLUS HAS BEEN TAKEN OFF THE BALANCED SIZER AND IS UNABLE TO BE PLACED BACK ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12227487 ↗
• MalfunctionJul 13, 2021Break; Crack; Break; Crack

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RED PIECE CRACKED ON BOTH SIZERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163800 ↗
• MalfunctionJul 13, 2021Break; Crack; Break; Crack

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RED PIECE CRACKED ON BOTH SIZERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163796 ↗
• MalfunctionMar 25, 2021Device-Device Incompatibility; Device-Device Incompatibility

  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 11568749 ↗
• MalfunctionMar 4, 2020Break; Break

  BALANCED SIZER BODY INSTRUMENT WAS NOTICED TO BE BROKEN INTRA-OP BEFORE HANDED TO THE SURGEON. A NEW BALANCED SIZER BODY WAS BROUGHT UP FOR STERILE PROCESSING DEPARTMENT.

  Patient problems: Not Applicable

  MAUDE report 9788528 ↗
• MalfunctionOct 10, 2019Difficult to Remove; Connection Problem; Device-Device Incompatibility; Difficult to Remove; Connection Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ATTUNE BALANCED FEMORAL SIZER WOULD NOT PROPERLY SLIDE OVER THE SIZING ROD. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9175333 ↗
• MalfunctionNov 28, 2018Device-Device Incompatibility; Device-Device Incompatibility

  INSTRUMENT KEEPS STICKING.

  Patient problems: Not Applicable

  MAUDE report 8112414 ↗
• MalfunctionNov 28, 2018Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THERE WAS CROSS THREADING.

  Patient problems: Not Applicable

  MAUDE report 8112380 ↗
• 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 7813466 ↗
• MalfunctionMar 21, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT ATTUNE BALANCE FEMORAL SIZER WAS TIGHT AND NOT SLIDING EASILY. MAY HAVE A TOLERANCE ISSUE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7357353 ↗
• MalfunctionJan 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT INSTRUMENT WILL NO LONGER AFFIX.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7193616 ↗