ATTUNE 2545-00-931Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295135081), received between Nov 17, 2017 and Dec 8, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Break; Break

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE "SHIM" GOT BROKEN IN PIECES. AS PER THE IMAGES ATTACHED. 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 23744835 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT THE SHIMS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438111 ↗
• MalfunctionApr 5, 2024Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE ATTUNE INSTRUMENTS ARE BROKEN WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049905 ↗
• MalfunctionApr 5, 2024Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE ATTUNE INSTRUMENTS ARE BROKEN WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049903 ↗
• 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 18875068 ↗
• MalfunctionJul 5, 2023Break; Crack; Break; Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259562 ↗
• MalfunctionJul 5, 2023Break; Crack; Break; Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17258195 ↗
• MalfunctionMar 10, 2022Break; Break

  CSSD IDENTIFIED THE BROKEN INSTRUMENTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721028 ↗
• MalfunctionSep 7, 2021Break; Break

  COMPASS CASE (B)(4) REPORT: IT WAS REPORTED THAT THE SPRING POPPED OUT OF THE HOLE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433625 ↗
• 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 11632024 ↗
• MalfunctionNov 6, 2020Break; Break

  INSTRUMENTS FOUND TO BE BROKEN DURING THE CLEANING AND STERILIZATION PROCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10802120 ↗
• MalfunctionSep 24, 2020Break; Break

  BROKEN ATTUNE INSTRUMENTS REPORTED BY CSSD STAFF. NO REPORT OF SURGICAL DELAY OR PATIENT CONSEQUENCES.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10584277 ↗
• MalfunctionJan 31, 2020Break; Break

  ATTUNE SZ 5-6 16MM SHIM AND SZ 8 RP PS TIBIAL INSERT REPORTED AS BROKEN BY CSSD STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9656027 ↗
• MalfunctionJan 29, 2020Break; Break

  IT WAS REPORTED THAT SHIMS ARE CRACKED AT METAL COVERING HOVE. NOT USE IN SURGERY. THIS IS ALL INFO THE SALES REP HAVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9644411 ↗
• MalfunctionDec 20, 2019Break; Break

  IT WAS REPORTED THAT THE SPACER BLOCK, TWO SHIMS, AND LOBSTER CLAW, AND CUP IMPACTOR WERE BROKEN DURING WASH. THESE WERE NOT USED IN SURGERY AND SURGERY WAS NOT DELAYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9506313 ↗
• MalfunctionJul 30, 2018Break; Break

  IT WAS REPORTED THAT THE STERILE PROCESSING IDENTIFIED CRACKS IN THE SHIMS. THESE WERE NOT USED IN THE CASE PRIOR. (B)(6) 2018: UPON EVALUATION, DEVICE WAS FOUND TO BE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7731287 ↗
• MalfunctionJul 10, 2018Break; Break

  IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN. DIDN'T IMPACT ANY CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7674826 ↗
• MalfunctionMay 10, 2018Crack; Crack

  SHIM HAS CRACKED AROUND THE METAL INSERT AREA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502387 ↗
• MalfunctionApr 25, 2018Break; Break

  IT WAS REPORTED THAT THE SHIM TRIALS BROKE DURING STERILE PROCESSING. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7457831 ↗
• MalfunctionApr 19, 2018Crack; Crack

  SHIM HAS CRACKED AROUND THE METAL INSERT AREA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7442682 ↗
• MalfunctionNov 17, 2017Break; Break

  IT WAS REPORTED THAT FOUR ATTUNE SHIMS WERE BROKEN/DAMAGED.

  Patient problems: No Information

  MAUDE report 7042585 ↗