ATTUNE 2545-00-745Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295134176), received between Jan 19, 2018 and May 11, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL KNEE. DURING TRIALING, THE TIBIAL INSERT SPACER SHIM BROKE INTO TWO PIECES. ALL PIECES WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136861 ↗
• 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 18875050 ↗
• MalfunctionAug 14, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT DEVICE WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541748 ↗
• MalfunctionMar 2, 2023Break; Break

  IT WAS REPORTED THAT THE PLASTIC OF SHIM WAS BROKEN IN TWO PIECES. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469816 ↗
• 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 15839144 ↗
• MalfunctionMay 17, 2021Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ATTUNE SHIM HAS CRACKED AROUND THE METAL INSERT AREA, ALSO ONE OF THE METAL LOCATION RINGS HAS COME OUT OF THE SHIM BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832553 ↗
• MalfunctionDec 17, 2020Break; Break

  EMAIL RECEIVED FROM CSSD DEPARTMENT AT SJOG MURDOCH WITH A LIST OF BROKEN INSTRUMENTS. THE INSTRUMENTS THAT ARE BROKEN WERE ALL FOUND TO BE BROKEN AFTER THE CLEANING PHASE OF USE. THE SURGERY THAT THEY WERE USED IN AND THE SURGEON USING THESE IS ALL UNKNOWN. THE DATE OF SURGERY AND THUS BREAKAGE IS ALSO UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11028971 ↗
• 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 11008981 ↗
• MalfunctionOct 22, 2020Break; Break

  IT WAS REPORTED THAT THE SHIM HAS BROKEN INTO MULTIPLE PIECES AND THIS WAS UNUSABLE. IT WAS NOT USED ON A PATIENT AND IT WILL BE RETURNED TO DEPUY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10720683 ↗
• MalfunctionApr 1, 2020Break; Crack; Break; Crack

  ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE DEVICES DID NOT BREAK. ONLY A SMALL CRACK WAS FOUND ON EACH DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9909182 ↗
• MalfunctionFeb 14, 2020Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SHIMS CRACKED AND NEED TO BE REPLACED. ONE OF THE BUSHINGS FELL OUT OF ONE OF THEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9711935 ↗
• MalfunctionDec 11, 2019Break; Crack; Break; Crack

  ALL ATTUNE SHIMS HAVE CRACKED AROUND THE METAL INSERT AREA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9450532 ↗
• MalfunctionJul 24, 2019Break; Break

  ATTUNE SHIMS HAVE ALL CRACKED AROUND THE METAL INSERT AREA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8821734 ↗
• MalfunctionMay 23, 2019Break; Crack; Break; Crack

  AFTER BEING USED DURING SURGERY, BEING WASHED AND STERILIZED SEVERAL TIMES, THE ATTUNE SHIMS SEEM TO BREAK EASILY. THE ITEMS BELOW NEED TO BE REPLACED IN (B)(6) HOSPITAL. DESCRIBE THE 'DAMAGE' OR 'OTHER' OUTCOME: NO DAMAGE TO PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636479 ↗
• MalfunctionJan 19, 2018Break; Break

  THERE IS A FISSURE IN THE WHITE PLASTIC. NO ADVERSE CONSEQUENCES FOR PATIENT OR USER. NO SURGERY DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7205149 ↗