ATTUNE 2544-01-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10603295395386), received between Jan 4, 2018 and Jun 1, 2026 — classified as 91 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (46 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 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SPRING ON THE ATTUNE SPACER BASE WAS STRETCHED AND DID NOT WORK. THE STRETCH WAS SLIGHT BUT WAS ENOUGH TO PREVENT THE SPACER FROM ENGAGING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349537 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT THE ROTATION PEG BROKE ON THE FLEXION/EXTENSION BLOCK CR EXTENSION/PS FLEXION SHIM WHILE DISASSEMBLING THE INSTRUMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817926 ↗
• MalfunctionApr 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE IMPACTED PRODUCT WOULD NOT FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24752416 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT ONE OF THE SPRINGS BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433675 ↗
• MalfunctionFeb 19, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT SPACER BASE WILL NO CLICK INTO SPACER BLOCK AND STAY IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397594 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT THE ATTUNE SPACER BASE WAS CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397527 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT (2) BROKEN PATELLA IN 2 SEPARATE TRAYS WERE FOUND (1) CR EXTENSION/PS FLEXION/EXTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189618 ↗
• MalfunctionJan 23, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY, THE FOLLOWING ISSUES WERE FOUND IN THE DEVICES: SPACER BLOCK AND SPACER BASE WERE LOOSE AND ALMOST CAME OFF A FEW TIMES WHEN THE SURGEON CHECKED EXTENSION GAP. IT WAS REPORTED THAT THE DEVICES WERE BEING USED WITH PATELLA DRILL (SPIKE) THAT COULD NOT INSERT INTO THE PATERA SMOOTHLY, AND A BATTERY POWERED HANDPIECE THAT WAS DIFFICULT TO INSERT DURING PEG DRILLING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172781 ↗
• MalfunctionJan 20, 2026Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROSCOPY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SPRING ON THE SHIM WAS LOOSE MAKING IT NOT ATTACH TO THE DOG BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116854 ↗
• MalfunctionDec 24, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE SPACER BASE HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888185 ↗
• MalfunctionDec 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPACER BASE DOES NOT SNAP INTO SPACER BLOCK. SOMETHING WRONG WITH LOCKING RING. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842779 ↗
• MalfunctionDec 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PS SHIM WOULD NOT SNAP ONTO THE SPACER BLOCK. THERE WAS NO DELAY TO THE PROCEDURE AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707285 ↗
• MalfunctionNov 4, 2025Break; Break

  IT WAS REPORTED THAT THE CENTER PEG OF THE DEVICE SNAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472574 ↗
• MalfunctionOct 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BEFORE A CASE, THE SCRUB TECH WAS ATTEMPTING TO PUT DOG BONE TOGETHER AND WAS UNABLE TO GET IT TO PROPERLY BE PUT TOGETHER WAS REMOVED FROM FIELD BEFORE PATIENT WAS IN ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439286 ↗
• MalfunctionOct 28, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, MEDICAL DEVICE REPROCESSING STATED THAT THEY CANNOT RE-STERILIZE THE ATTUNE SHIMS, FEMORAL TRIALS AND IMPACTORS IN THE SETS DUE TO THEM HAVING MULTIPLE CHIPS AND MICRO CRACKS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401318 ↗
• MalfunctionOct 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SPACER BASE WAS NOT CLIPPING INTO THE SPACER BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23327915 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2025. THE SPACER BASE WAS BROKEN UPON INSPECTION. THERE WAS NO DELAY TO CASE OR PATIENT HARM. IT WAS FOUND PRIOR TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310012 ↗
• MalfunctionJul 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPACER BASE DOES NOT SNAP IN TO SPACER BLOCK. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636852 ↗
• MalfunctionJul 24, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPRING ON CR/PS EXTENSION PIECE IS BROKEN, NOT ALLOWING TO CLIP INTO THE SPACER BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592149 ↗
• MalfunctionJul 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENTS NEEDED TO BE REPLACED. THERE WERE IMPERFECTIONS UPON INSPECTION. IT WAS NOT USED ON A PATIENT. THERE WERE NO ADVERSE EFFECTS OR CASE DELAYS. THE SHIM WAS CRACKED; THE SPACER BASE WOULDN'T CONNECT. THERE WAS SMALL CRACK ON THE FEMUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383585 ↗
• MalfunctionJul 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENTS NEED REPLACING. IMPERFECTIONS WERE SEEN UPON INSPECTION. THEY WERE NOT USED ON A PATIENT. THERE WAS NO ADVERSE EFFECTS, NO CASE DELAYS. THE SHIM WAS CRACKED. THE SPACER BASE WON'T CONNECT. FEMUR HAD A SMALL CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382372 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT THE SPACER BASE WOULD SNAP INTO THE SPACER BLOCK. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337786 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SPRING ON THE SPACER BASE SNAPPED. CASE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176832 ↗
• MalfunctionMay 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPACER BASE WOULD NOT CONNECT TO THE SPACER. SHIM WAS NOTICED TO BE CRACKED. INSTRUMENTS WERE NOT USED FOR CASE. THERE WERE NO ADVERSE EFFECTS FOR THE PATIENT. THERE WERE NO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069042 ↗
• MalfunctionMay 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPACER BASE WILL NO LONGER SNAP ON TO THE SPACER BLOCK. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 22020887 ↗