ATTUNE 2545-00-692Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10603295133643), received between Jul 20, 2017 and Oct 28, 2025 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 38 reports, in the reporter's own words as published by the FDA.

• 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 23401317 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS BROKE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21761149 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE TRAY WAS OPENED IT WAS NOTICED THAT THE SHIM WAS BROKEN. IT WAS NOT USED DURING THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21257983 ↗
• MalfunctionApr 1, 2024Break; Crack; Break; Crack

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE SHIM SPLIT IN THE MIDDLE. NO, IT DID NOT SPLIT INTO 2 PIECES. IT IS STILL IN ONE PIECE. NO DELAYS IN SURGERY AND NO PATIENT HARM OCCURRED.

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

  MAUDE report 19010862 ↗
• MalfunctionMar 11, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SHIMS WERE CRACKED/MISSING METAL CONNECTING PIECES.

  Patient problems: Insufficient Information

  MAUDE report 18874690 ↗
• MalfunctionFeb 12, 2024Break; Break

  IT WAS REPORTED THAT AFTER THE TRIALING PROCESS OF THE SIZE 9/10 CR 6 MM SHIM AND TRIALING SURFACE, THE SURGEON BEGAN TO REMOVE THE INSERT TRIAL AND BOTH THE METAL RINGS ON THE SHIM HAD BROKEN OFF. ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD IMMEDIATELY AND THERE WAS NO HARM TO THE PATIENT OR DELAY IN THE PROCEDURE. THE CASE WAS FINISHED TRIALING WITH A SIZE 8, 6MM SHIM AND PROCEEDED WITHOUT DELAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18683942 ↗
• MalfunctionJun 21, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN FROM CONTINUAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17173036 ↗
• MalfunctionMar 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE METAL RINGS IN SHIM FELL OUT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469981 ↗
• MalfunctionJan 27, 2023Break; Break

  IT WAS REPORTED THAT TIBIAL TRIAL WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251884 ↗
• MalfunctionDec 8, 2022Break; Break

  IT WAS REPORTED THAT INSTRUMENT BROKE DURING KNEE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15943517 ↗
• MalfunctionNov 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING INSTRUMENT INSPECTION IT WAS NOTICED THAT THE METAL INSERTS IN THE SHIM HOLES ARE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15840551 ↗
• MalfunctionAug 15, 2022Break; Break

  IT WAS REPORTED THAT THE ATTUNE SHIM BROKE DURING TOTAL KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15223945 ↗
• MalfunctionAug 5, 2022Break; Break

  IT WAS REPORTED THAT AN EMAIL RECEIVED FROM CSSD TECH WITH A LIST OF BROKEN INSTRUMENTS THAT HAVE BEEN COLLECTED IN CSSD. EMAIL CONTAINS ALL ITEMS FROM CONSIGNMENT SETS. NO INFORMATION IS PROVIDED AS TO HOW THE BROKE, OR THE EXTENT OF DAMAGE THAT HAS BEEN INCURRED. ITEMS ONLY CONTAIN BATCH CODES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15173677 ↗
• MalfunctionJul 27, 2022Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  INSTRUMENTS ARE BROKEN. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15115413 ↗
• MalfunctionJun 8, 2022Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14631047 ↗
• MalfunctionJun 2, 2022Crack; Crack

  DURING AN INSPECTION AT THE CUSTOMER LOCATION IT WAS NOTICED THAT THE REPORTED ITEM HAVE CRACKS. NO FRAGMENTS WERE CREATED. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14577369 ↗
• MalfunctionApr 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  TRIAL WILL NOT SNAP ON TO ARTICULATING SURFACE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102995 ↗
• MalfunctionJan 18, 2022Break; Break

  IT WAS REPORTED THAT THE SHIM BROKE IN HALF ON THE BACK TABLE WHEN TRYING TO CONNECT IT TO THE MODULAR INSERT. NEVER TOUCHED THE PATIENT. ALL PIECES RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13283195 ↗
• MalfunctionSep 3, 2021Break; Break

  IT WAS REPORTED THAT THE SHIM 9-10 6MM BROKE. ALSO TOO THERE IS A FRACTURE IN THE 9-10 MACRO TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421713 ↗
• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED THAT THE 9/10X6MM SHIM WAS FOUND BROKEN INTO TWO PIECES WHILE CLEANING TRAYS UP. ALL PIECES ARE ACCOUNTED FOR. RIGID HEX DRIVER WAS ALSO FOUND BROKEN. THE TIP WAS SNAPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649131 ↗
• MalfunctionMar 19, 2021Break; Break

  IT WAS REPORTED THAT THE STERILE PROCESSING NOTICED A CHIP ON THE RIGHT INSIDE CENTER OF THE SHIMS IN SIZES 9&10 5MM AND 6MM. NO ONE SAID ANYTHING ABOUT THE CHIP DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530594 ↗
• MalfunctionFeb 3, 2021Break; Break

  IT WAS REPORTED THAT SHIM BROKE INTO 2 PIECES WHEN PUTTING THE KNEE INTO EXTENSION (WITH FORCE FROM SURGEON) BOTH PIECES POPPED OUT OF THE PATIENT AND ONTO THE FLOOR. ALL PIECES WERE ACCOUNTED FOR. THIS DID NOT DELAY SURGERY. NO PIECES LANDED IN THE PATIENT. SURGEON DOES NOT WISH TO BE CONTACTED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11275690 ↗
• MalfunctionDec 15, 2020Break; Break

  IT WAS REPORTED THAT SHIMS FOUND BROKEN IN STERILE PROCESSING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11008973 ↗
• MalfunctionOct 19, 2020Break; Break

  IT WAS REPORTED THAT THE SPRING ON THE ARTICULAR SURFACE TRIAL WAS DEFORMED AND THE METAL RING ON THE 9-10 OF A 6MM SHIM WAS POPPING OUT. THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10698708 ↗
• MalfunctionApr 1, 2020Break; Crack; Break; Crack

  BROKEN ATTUNE SHIMS REPORTED BY CSSD STAFF. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? - UNKNOWN, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? -> UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? - UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES -UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: - UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY - UNKNOWN, IP-00860129. DEVICE PROPERTY OF -NONE, DEVICE IN POSSESSION OF -NONE, IP-00860130. DEVICE PROPERTY OF -NONE, DEVICE IN POSSESSION OF -NONE, IP-00860131. DEVICE PROPERTY OF -NONE, DEVICE IN POSSESSION OF -NONE, IP-00860132. DEVICE PROPERTY OF -NONE, DEVICE IN POSSESSION OF -NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.- TRUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9909185 ↗