ATTUNE 2545-00-943Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295135203), received between May 15, 2018 and Oct 31, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT THE SHIMS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435337 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT THE SHIMS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435318 ↗
• 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 20821309 ↗
• 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 19563289 ↗
• 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 18856967 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT TIBIAL TRIAL IS BROKEN. IF OTHER, DESCRIBE: I WAS INFORMED BY THE STAFF IN CENTRAL SUPPLY THAT THE ATTUNE INSTRUMENT WAS BROKEN. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO PATIENT INVOLVEMENT. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NONE. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO. IF YES, DESCRIBE: NONE. 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 18605988 ↗
• MalfunctionMay 26, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO DESCRIPTION OF THE DAMAGE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009864 ↗
• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED THAT MULTIPLE SHIMS WERE DISCOVERED TO BE CRACKED AND NEED TO BE REMOVED AND REPLACED. ALL PIECES WERE RETRIEVED. NO TIME DELAY EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815130 ↗
• MalfunctionApr 24, 2023Break; Break

  IT WAS REPORTED THAT DEVICE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796118 ↗
• 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 15145824 ↗
• 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 12089831 ↗
• MalfunctionJun 15, 2021Break; Crack; Break; Crack

  EMAIL RECEIVED FROM CSSD ORTHOTECH REPORTING THAT THE OF INSTRUMENTS BROKE. THE TIBIAL RP IMPACTOR AND TWO SHIMS HAVE CRACKED THROUGH THE MAIN BODY OF THE INSTRUMENT. THEY REMAIN INTACT AND IN ONE PIECE. ALL INSTRUMENTS ARE FROM CONSIGNMENT SETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12004967 ↗
• 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 11630288 ↗
• MalfunctionJan 13, 2021Break; Break

  BROKEN INSTRUMENTS SUSTAINED OVER THE CHRISTMAS PERIOD. EMAIL PROVIDES DETAILS OF WHAT INSTRUMENTS ARE BROKEN WITH THE RELEVANT BATCH NUMBERS. THE EMAIL DOES NOT PROVIDE INFORMATION ON WHERE OR HOW THESE INSTRUMENTS BROKE AND IF DEBRIS WAS GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11166815 ↗
• MalfunctionJan 13, 2021Break; Break

  BROKEN INSTRUMENTS SUSTAINED OVER THE CHRISTMAS PERIOD. EMAIL PROVIDES DETAILS OF WHAT INSTRUMENTS ARE BROKEN WITH THE RELEVANT BATCH NUMBERS. THE EMAIL DOES NOT PROVIDE INFORMATION ON WHERE OR HOW THESE INSTRUMENTS BROKE AND IF DEBRIS WAS GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11166772 ↗
• MalfunctionNov 12, 2020Break; Break

  EMAIL RECEIVED FROM CSSD DEPARTMENT OF (B)(6) HOSPITAL WITH BROKEN INSTRUMENTS THAT HAVE BEEN FOUND DURING THE CLEANING AND STERILIZATION STAGES.

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

  MAUDE report 10830610 ↗
• MalfunctionMar 24, 2020Break; Break

  BROKEN 4 X ATTUNE SHIMS AND EXCEL T HANDLE REPORTED BY CSSD STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9871122 ↗
• 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 7515235 ↗