ATTUNE 2545-00-921Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL SHIM SIZE 3 20mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE conventional shim is a trial sizing instrument used during joint replacement surgery to check fit before the real implant goes in. The reports mostly describe shims breaking or cracking, sometimes during sterilization or even while still in the packaging, with metal connecting pieces going missing. There are 27 reports, no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295134985), received between Jul 30, 2018 and Aug 27, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Break” (24 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.
Reports received per month
Most reported problems
Device problems
- Break24
- Crack9
- Detachment of Device or Device Component2
- No Apparent Adverse Event2
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient5
- Insufficient Information2
- No Code Available1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Break
It was reported that the instruments were broken.Was there any reported patient or user harm? No.Was there a significant delay? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50483914 ↗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 23582503 ↗MalfunctionMay 5, 2025Break; Break
IT WAS REPORTED THAT THERE WERE SOME BROKEN INSTRUMENTS. NO OTHER INFORMATION WAS PROVIDED AT THE TIME.
Patient problems: Insufficient Information
MAUDE report 21962196 ↗MalfunctionJul 24, 2024Crack; Crack
EACH INSTRUMENT IS COMPOSED OF 1 PART. EACH INSTRUMENT CONTAINS CRACKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19818179 ↗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 18875067 ↗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 18857081 ↗MalfunctionSep 5, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THERE WAS A CRACK IN THE PLASTIC PART OF THE SHIM. THERE IS NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17681860 ↗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 17277071 ↗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 17259205 ↗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 17254226 ↗MalfunctionMay 1, 2023Break; Break
IT WAS REPORTED THAT A LIST OF BROKEN INSTRUMENTS WERE SUBMITTED WITHOUT DESCRIPTION OF HOW THE ITEMS BROKE OR THE EXTENT OF THE DAMAGE THAT HAS OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16843252 ↗MalfunctionApr 6, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE HOSPITAL CHECKED INSTRUMENT KITS AND FOUND INSTRUMENTS WHICH NEEDED TO BE REPLACED, NO DIRECT IMPACT ON A THE CASE. THE SHIMS WERE FOUND BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16688617 ↗MalfunctionApr 6, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE HOSPITAL CHECKED INSTRUMENT KITS AND FOUND INSTRUMENTS WHICH NEEDED TO BE REPLACED, NO DIRECT IMPACT ON A THE CASE. THE SHIMS WERE FOUND BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16688615 ↗MalfunctionJan 31, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
EMAIL RECEIVED FROM CSSD TECH WITH A LIST OF BROKEN CONSIGNMENT ATTUNE INSTRUMENTS. EMAIL CONTAINED ONLY THE REF CODES FOR THE SHIMS. THERE WAS NO OTHER DETAILS PROVIDED. NO LOT CODES WERE ALSO PROVIDED. REP ONSITE ON TUESDAY AND WILL CHASE UP LOT CODES. NO DESCRIPTION OF DAMAGE OR HOW THE DAMAGE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16275144 ↗MalfunctionJan 31, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
EMAIL RECEIVED FROM CSSD TECH WITH A LIST OF BROKEN CONSIGNMENT ATTUNE INSTRUMENTS. EMAIL CONTAINED ONLY THE REF CODES FOR THE SHIMS. THERE WAS NO OTHER DETAILS PROVIDED. NO LOT CODES WERE ALSO PROVIDED. REP ONSITE ON TUESDAY AND WILL CHASE UP LOT CODES. NO DESCRIPTION OF DAMAGE OR HOW THE DAMAGE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16275124 ↗MalfunctionJan 31, 2023Break; Break
EMAIL RECEIVED FROM CSSD TECH WITH A LIST OF BROKEN CONSIGNMENT ATTUNE INSTRUMENTS. EMAIL CONTAINED ONLY THE REF CODES FOR THE SHIMS. THERE WAS NO OTHER DETAILS PROVIDED. NO LOT CODES WERE ALSO PROVIDED. REP ONSITE ON TUESDAY AND WILL CHASE UP LOT CODES. NO DESCRIPTION OF DAMAGE OR HOW THE DAMAGE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16274902 ↗MalfunctionJan 31, 2023Break; Break
EMAIL RECEIVED FROM CSSD TECH WITH A LIST OF BROKEN CONSIGNMENT ATTUNE INSTRUMENTS. EMAIL CONTAINED ONLY THE REF CODES FOR THE SHIMS. THERE WAS NO OTHER DETAILS PROVIDED. NO LOT CODES WERE ALSO PROVIDED. REP ONSITE ON TUESDAY AND WILL CHASE UP LOT CODES. NO DESCRIPTION OF DAMAGE OR HOW THE DAMAGE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16274888 ↗MalfunctionJul 21, 2022Break; Crack; Break; Crack
IT WAS REPORTED THAT 3/4 20MM SHIM WAS CRACKED AND BROKEN INTO TWO PIECES. THIS HAPPENED AFTER THE CASE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15075184 ↗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 12923739 ↗MalfunctionApr 30, 2021Break; Break
INFORMED BY ORTHOTECH OF BROKEN SHIM. THE SHIM IS TAGGED AS DAMAGED AND STERILE/ READY FOR COLLECTION. PLEASE MAY WE HAVE IT REPLACED. PICK UP AND RETURN OF NEW ONE TO (B)(6) HOSPITAL. TRAY NUMBER- UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11753413 ↗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 11630246 ↗MalfunctionDec 29, 2020Break; Break
EMAIL RECEIVED FROM CSSD CO-ORDINATOR AT (B)(6) WITH A WEEKLY UPDATE OF INSTRUMENTS THAT HAVE BEEN FOUND TO BE BROKEN FOLLOWING THE CLEANING AND STERILISATION PROCESS. THE HOSPITAL HAS PROVIDED THE DETAILS OF THE BROKEN INSTRUMENTS, HOWEVER, THE CASE THEY WERE INVOLVED IN, HOW THEY BROKE IS ALL UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11089473 ↗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 10584288 ↗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 9871125 ↗MalfunctionMar 13, 2020Break; Break
CSSD STAFF REPORTED BROKEN 2 X ATTUNE ARTICULATING SURFACE SZ 5 RP, SZ 5/6 6MM POLY TRIAL, PS 20 MM POLY TRIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9832568 ↗
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- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
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- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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