ATTUNE 2544-01-014Recalls & reported problems

Summary

The FDA's MAUDE database contains 802 adverse event reports that list this exact device (DI 10603295395379), received between Feb 8, 2016 and Sep 30, 2026 — classified as 2 injuries, 800 malfunctions.

The most frequently reported specific device problem is “Break” (467 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 25 most recent of 802 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported that the Spring was broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946228 ↗
• MalfunctionSep 25, 2026Break

  It was reported that during a Total Knee Arthroplasty (TKA) surgical procedure, the device springs broke.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898162 ↗
• MalfunctionSep 21, 2026Contamination /Decontamination Problem; Material Integrity Problem

  It was reported that the Attune Spacer block was damaged; unable to be sterilized in current condition. There was no reported patient or user harm. There was no significant delay reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843174 ↗
• MalfunctionSep 14, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50764057 ↗
• MalfunctionSep 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595235 ↗
• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50554652 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548616 ↗
• MalfunctionAug 31, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50531410 ↗
• MalfunctionJun 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE, THE INSTRUMENT SET LITTLE SPRINGS WERE MISSING ON THE ATT CR TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664863 ↗
• MalfunctionJun 30, 2026Detachment of Device or Device Component

  THERE ARE 2 SPRING FITTED ON THE BACK OF THE TRIAL SURFACES. IT WAS IDENTIFIED BY STERILE SERVICES THAT THIS TRIAL SURFACE HAD ONE OF THE 2 SPRINGS MISSING. THIS DID NOT OCCUR INTRAOPERATIVELY AND MUST HAVE BEEN WHILE BEING WASHED OR STERILIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664639 ↗
• MalfunctionJun 22, 2026Break

  IT WAS REPORTED THAT THE WHITE PEG ON THE END OF THE SPACER BLOCK IS CHIPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25580392 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT A PIECE OF THE DEVICE BROKE OFF THE FEMUR TRIAL. THE TAB BROKE OFF THE SPACER BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364117 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN INSPECTING THE INSTRUMENT PRIOR TO SURGERY, IT WAS NOTICED THAT THE SPRING ON THE SPACER BLOCK WAS MISSING. THE ITEM WAS NOT USED DURING THE CASE, AND THERE WERE NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337208 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT PLASTIC KNOB ON THE ATTUNE SPACER BLOCK WAS BROKEN. NO PIECES WERE LEFT IN THE PATIENT. THERE WERE 3 PIECES TOTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25277817 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT THE SPACER BLOCK WAS ACCIDENT IMPACTED WHILE TRIALING EXTENSION. THE INSTRUMENT WAS BROKEN INTO MULTIPLE SMALL PIECES BUT ALL PARTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215280 ↗
• MalfunctionMay 14, 2026Material Deformation

  IT WAS REPORTED THAT WHEN CLEANING SPACER BLOCK SPRINGS LOOSENED. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175857 ↗
• MalfunctionMay 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRINGS ON THE SPACER BLOCK WERE COMING OFF. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174689 ↗
• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT ATTUNE SPACER BLOCK IS BROKEN. ALL PIECES RETRIEVED. NO DELAY. NO COMPLICATIONS. PARTS WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173185 ↗
• MalfunctionMay 1, 2026Break; Crack

  IT WAS REPORTED ONE OF THE CIRCULAR RINGS THAT SHIMS SNAP ONTO WAS CRACKED AND A SMALL PIECE BROKE AWAY. IT WAS DISCOVERED WHILE PUTTING INSTRUMENT SETS BACK TOGETHER IN THE STERILE PROCESSING DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055356 ↗
• MalfunctionApr 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPACER BLOCK WAS MISSING THE SPRING THAT LOCKS DOWN SHIMS FOR GAP CHECKING. THIS DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982439 ↗
• MalfunctionApr 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRINGS WERE GONE ON THE ATTUNE SPACER BLOCK, AND THE ATTUNE PIN JACK WILL NOT JACK OFF THE PINS ANYMORE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965850 ↗
• MalfunctionApr 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRINGS WERE GONE ON THE ATTUNE SPACER BLOCK, AND THE ATTUNE PIN JACK WILL NOT JACK OFF THE PINS ANYMORE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965801 ↗
• MalfunctionApr 17, 2026Crack

  IT WAS REPORTED THAT THE SPACER BLOCK HANDLE WAS CRACKED AT THE SHIM ATTACHMENT POINT. THERE WAS NO PATIENT HARM OR SURGICAL DELAY. ALL PARTS ARE ACCOUNTED FOR. THIS EVENT DID NOT OCCUR DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913563 ↗
• MalfunctionApr 16, 2026Detachment of Device or Device Component

  SPRINGS HAVE FALLEN OFF ALL THE SPACER BLOCKS FROM NORMAL USE AND SHIMS WILL NO LONGER SELF RETAIN. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24902360 ↗
• MalfunctionApr 16, 2026Detachment of Device or Device Component

  SPRINGS HAVE FALLEN OFF ALL THE SPACER BLOCKS FROM NORMAL USE, AND SHIMS WILL NO LONGER SELF RETAIN. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24893174 ↗