ATTUNE 2545-00-920Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295134978), received between Jan 10, 2019 and Nov 18, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 16 most recent of 16 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 23582419 ↗
• 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 20821318 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT THE SHIMS WERE FOUND TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563293 ↗
• 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 18874590 ↗
• 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 17277046 ↗
• 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 17255082 ↗
• MalfunctionApr 11, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT DEVICE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16716429 ↗
• MalfunctionAug 2, 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 THEY 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 15145821 ↗
• MalfunctionDec 30, 2021Break; Break

  THE ATTUNE FEMORAL IMPACTOR WAS CRACKED AND IS NOW IN TWO SEPARATE PIECES. THE CRACK EXTENDED FROM THE POSTERIOR DISTAL PORTION TO THE ANTERIOR PROXIMAL PORTION OF THE IMPACTOR. THE ATTUNE SHIM HAS A CRACK THAT EXTENDS FROM THE METAL DRILL GUIDE TO THE OUTSIDE EDGE OF THE SHIM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117387 ↗
• MalfunctionDec 3, 2021Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ATTUNE SHIM HAS CRACKED AROUND THE METAL INSERT AREA. ALSO ON TWO OF THE SHIMS THE METAL INSERT HAS STATED TO COME OUT OF SHIM BODY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923790 ↗
• MalfunctionOct 27, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT ONE OF THE FEMORAL IMPACTORS HAS CRACKED INTO 2 PIECES WITH BOTH PARTS BEING RETAINED. THE OTHER IMPACTOR HAS A CRACK DOWN THE MIDDLE BUT REMAINS IN ONE PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12703962 ↗
• MalfunctionMar 14, 2020Break; Break

  CSSD STAFF REPORTED BROKEN ATTUNE PS 20 MM POLY TRIAL, ATTUNE PS 18 MM POLY TRIAL, SROM TRIANGLE MILLER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832583 ↗
• MalfunctionJun 24, 2019Break; Break

  IT WAS REPORTED THAT THE SPD NOTIFIED THE SALES REP THAT THE 18MM SHIM WAS CRACKED. IT WAS NOT USED IN SURGERY. BROKEN INTO 2 PIECES AND WERE BOTH RECOVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8726545 ↗
• MalfunctionMar 29, 2019Break; Crack; Break; Crack

  IT WAS REPORTED THAT THREE ATTUNE SHIMS WERE FOUND TO BE CRACKED OR BROKEN BY A SURGICAL TECH DURING A ROUTINE INSTRUMENTATION INSPECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8465486 ↗
• MalfunctionJan 24, 2019Crack; Crack

  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 SHIMS BROKE DURING THE WASH OR STERILIZER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8273909 ↗
• MalfunctionJan 10, 2019Break; Break

  IT WAS REPORTED THAT THE STERILE PROCESSING DEPARTMENT 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 WASH OR STERILIZER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8235597 ↗