ATTUNE 2545-00-933Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295135104), received between Nov 9, 2017 and Nov 18, 2025 — 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.

• 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 23583469 ↗
• MalfunctionJan 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT SILVER RING CAME OFF THE 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. (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 18464306 ↗
• MalfunctionMay 26, 2023Break; Break

  IT WAS REPORTED THAT DEVICE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009823 ↗
• MalfunctionMay 26, 2023Break; Break

  IT WAS REPORTED THAT DEVICE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009815 ↗
• 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 12923760 ↗
• MalfunctionApr 7, 2021Break; Break

  EMAIL RECEIVED FROM CSSD DEPARTMENT AT MURDOCH WITH A LIST OF BROKEN INSTRUMENTS THAT THEY HAVE FOUND OVER THE COURSE OVER THE LAST WEEK. EMAIL CONTAINS A LIST OF INSTRUMENTS WITH THEIR CODES BUT NO INFORMATION ABOUT HOW THEY BROKE OR WHAT PARTS OF THE INSTRUMENTS ARE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11630214 ↗
• MalfunctionJul 28, 2020Break; Break

  BROKEN ATTUNE SHIMS, FEMORAL TRIAL AND PIN PULLER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10335885 ↗
• 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 9832585 ↗
• MalfunctionApr 29, 2019Break; Break

  IT WAS REPORTED THAT THE SHIM WAS FOUND TO BE BROKEN THROUGH THE CENTER OF THE SHIM WHILE GOING THROUGH THE STERILIZATION PROCESS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8561042 ↗
• MalfunctionFeb 12, 2019Break; Crack; Break; Crack

  IT WAS REPORTED THAT STERILE PROCESSING ADVISED THAT A NUMBER OF SHIMS FROM ATTUNE SHIMS AND GENERAL TRAY WERE CRACKED AND BROKEN AND WOULD NOT BE ADEQUATELY AND SAFELY PROCESSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332252 ↗
• MalfunctionMay 14, 2018Crack; Crack

  SHIM HAS CRACKED AROUND THE METAL INSERT AREA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7510132 ↗
• 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 7457842 ↗
• MalfunctionFeb 21, 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 7285684 ↗
• MalfunctionNov 17, 2017Break; Break

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

  Patient problems: No Information

  MAUDE report 7042645 ↗
• 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 7015002 ↗