ATTUNE 2545-00-944Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295135210), received between Jul 13, 2017 and Nov 18, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT THE SHIM TRIALS WERE BROKEN DURING STERILIZATION PROCESS. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583304 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT SPD STAFF ADVISED THAT SHIMS WERE CRACKED AND/OR BROKEN AND NEED REPLACED TO ENSURE THOROUGH STERILIZATION. THERE WAS NO DELAY IN CASE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821305 ↗
• MalfunctionApr 9, 2024Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE ATTUNE INSTRUMENTS ARE BROKEN AND WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070040 ↗
• MalfunctionMar 7, 2024Break; Break

  IT WAS REPORTED THAT THE SHIM IS BROKEN. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18856933 ↗
• MalfunctionMar 7, 2024Break; Break

  IT WAS REPORTED THAT THE SHIM IS BROKEN. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18856915 ↗
• MalfunctionFeb 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE METAL RINGS ARE PROTRUDING OUTWARD EXCESSIVELY. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18670461 ↗
• MalfunctionJan 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS SILVER RING POPPING OUT FROM THE ATTUNE SHIM. PATIENT STATUS/ OUTCOME / CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18454718 ↗
• MalfunctionJul 7, 2023Break; Break

  IT WAS REPORTED THAT THE SHIM TRIALS WERE FOUND TO HAVE CRACKS IN THEM. THIS DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17277101 ↗
• MalfunctionApr 19, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT SHIM WAS CRACKED AND TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769623 ↗
• MalfunctionMar 7, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497049 ↗
• MalfunctionJun 29, 2021Break; Break

  IT WAS REPORTED BY CSSD ORTHOTECH THERE WERE BROKEN INSTRUMENTS. THE DATE OF EVENT IS UNKNOWN FOR THE BREAKAGE. IT ISN'T BROKEN INTO TWO OR MORE PIECES. THE EXTENT OF THE DAMAGE IS UNKNOWN AT THIS STAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089833 ↗
• MalfunctionApr 7, 2021Break; Break

  IT WAS REPORTED THAT THE ATTUNE SHIMS AND EXCEL T-HANDLE WAS BROKEN. NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11632021 ↗
• MalfunctionJul 28, 2020Break; Break

  BROKEN ATTUNE SHIMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10335826 ↗
• MalfunctionJun 11, 2020Crack; Crack

  IT WAS REPORTED THAT THE ATTUNE SHIMS ARE CRACKED AND NEEDS TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10143762 ↗
• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED THAT THE SZ 7-8 18 MM SHIM WAS CRACKED IN TWO PIECES. IT WAS CRACKED FROM THE FRONT ANTERIOR PORTION TO THE PEG HOLE. THEN AFTER SEEING THE CRACK AND PUTTING IT ON THE TABLE IT BROKE INTO 2 PIECES. NOT MUCH FORCE WAS APPLIED AT ALL WHEN PUTTING IT ON THE TABLE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9105527 ↗
• MalfunctionJan 10, 2019Break; Crack

  IT WAS REPORTED THAT THE STERILE PROCESSING ADVISED THAT A NUMBER OF SHIMS FROM ATTUNE'S SHIMS AND GENERAL TRAY WERE CRACKED AND BROKEN AND COULD NOT BE ADEQUATELY AND SAFELY PROCESSED. IT APPEARS THE SHIMS BROKE DURING THE WAS OR STERILIZER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8235487 ↗
• MalfunctionAug 7, 2018Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE ATTUNE SHIMS CRACKED. REP FOUND DURING INSPECTION AND NOT DURING SURGERY. NO FURTHER INFORMATION CAN BE PROVIDED. NO SURGICAL DELAY. UPDATE 7/13/2018: EXAMINATION OF THE RETURNED DEVICE FINDS THE SHIM IS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7757253 ↗
• MalfunctionMay 15, 2018Crack; Crack

  SHIM HAS CRACKED AROUND THE METAL INSERT AREA. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7515139 ↗
• MalfunctionNov 9, 2017Break; Break

  IT WAS REPORTED THAT ATTUNE SHIMS CONTINUED TO CRACK AND BREAK APART. THEY KEPT ON SWITCHING TO OTHER SIZES TO MAKE IT WORK AND BROKE MANY.

  Patient problems: No Information

  MAUDE report 7014170 ↗
• MalfunctionJul 13, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE ATTUNEM SHIM SZ5 14MM AND ATTUNEM SHIM SZ7 16MM HAVE CRACKED AROUND THE METAL INSERT AREA. IT WAS ALSO REPORTED THAT THE ATTUNEM SHIM SZ7 18MM HAS STARTED TO COME OUT OF THE SHIM BODY.

  Patient problems: No Information

  MAUDE report 6710315 ↗