ATTUNE 2545-00-940Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL SHIM SIZE 7 10mm · 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 small orthopedic spacer used during joint replacement surgery. The 45 reports describe shims arriving cracked, split, or broken — often found before surgery or after sterilization, and in some cases the articulating surface was also broken and had to be replaced. No deaths or injuries were reported. There are no recalls naming this device, and reports have continued steadily, with 3 in the last 12 months.
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
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10603295135173), received between Sep 7, 2017 and Mar 6, 2026 — classified as 45 malfunctions.
The most frequently reported specific device problem is “Break” (32 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
- Break32
- Crack15
- Detachment of Device or Device Component4
- Component Missing2
- Adverse Event Without Identified Device or Use Problem1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Consequences Or Impact To Patient15
- Insufficient Information2
- No Information1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2026Break
IT WAS REPORTED THAT THERE WAS A SHIM, SIZE 8/7, 10 MM, THAT IS SPLIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24530282 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THE SURGEON WAS HANDED A BROKEN SHIM FROM ORTHOTECH AT THE HOSPITAL. THERE WAS NO INFORMATION ON HOW THE DEVICE WAS DAMAGED PROVIDED, ONLY THAT IT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24075921 ↗MalfunctionDec 24, 2025Break; Break
IT WAS REPORTED THAT THE SHIMS AND ARTICULATING SURFACE WERE BROKEN AND NEEDED TO BE REPLACED. BROKEN INSTRUMENTS WERE NOT USED IN SURGERY AND THERE WAS NO DELAY CAUSED THEREFROM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888872 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438239 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437025 ↗MalfunctionMar 31, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THE SPD STAFF ADVISED THAT THE SHIM WAS CRACKED AND CAN'T BE STERILIZED. THE CRACK DIDN'T HAPPEN DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21732244 ↗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 20821327 ↗MalfunctionNov 8, 2024Break; Material Deformation; Break; Material Deformation
ADDITIONAL INFORMATION RECEIVED STATES THAT THEY ARE NOT SURE IF THE DEVICE BROKE INTO TWO OR MORE PIECES. THERE WAS NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20645288 ↗MalfunctionMar 20, 2024Break; Break
BROKEN/ DAMAGED INSTRUMENTS AT HOSPITAL NEEDING REPLACEMENTS. NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18941999 ↗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 18874538 ↗MalfunctionFeb 1, 2024Break; Break
INSTRUMENTS WERE REPORTED FOR UNKNOWN ALLEGATION. IT DID NOT HAPPEN IN SURGERY. VISUAL EXAM OF THE RETURNED DEVICE FOUND IT TO BE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18628549 ↗MalfunctionJan 11, 2024Break; Crack; Break; Crack
IT WAS REPORTED THAT THE 10MM SHIMS HAVE CRACKS AND ONE BROKE INTO 2 PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18497602 ↗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 18464365 ↗MalfunctionDec 7, 2023Break; Break
IT WAS REPORTED THAT SHIM IS BROKEN. , 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 HOSPITAL, DEVICE IN POSSESSION OF SALES REP 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 18288041 ↗MalfunctionNov 20, 2023Break; Break
WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18169572 ↗MalfunctionOct 18, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE DEVICE IS CRACKED AND CHIPPED. 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. (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 17954635 ↗MalfunctionSep 28, 2023Crack; Crack
IT WAS REPORTED THAT THE TRIAL SHIM WAS FOUND TO BE CRACKED. THERE WERE NO ADVERSE EFFECTS AND NO TIME ADDED TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17834891 ↗MalfunctionApr 20, 2023Break; Break
IT WAS REPORTED THAT THE SHIM BROKE INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16776252 ↗MalfunctionApr 10, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE DEVICE IS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16710592 ↗MalfunctionApr 10, 2023Break; Crack; Break; Crack
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY OR SURGERY THAT TOOK PLACE. THIS DER WAS COMPLETED IN RESPONSE TO THE HOSPITAL BEING PROACTIVE AND REALIZING THAT THE INSTRUMENTS THAT STAYED AT THE HOSPITAL WERE A SAFETY HAZARD TO PATIENTS HAVING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16710585 ↗MalfunctionApr 10, 2023Break; Crack; Break; Crack
ADDITIONAL INFORMATION RECEIVED. INDICATES, THAT THERE WAS NO SURGICAL DELAY OR SURGERY THAT TOOK PLACE. THIS DER WAS COMPLETED IN RESPONSE TO THE HOSPITAL BEING PROACTIVE. AND REALIZING, THAT THE INSTRUMENTS THAT STAYED AT THE HOSPITAL WERE A SAFETY HAZARD TO PATIENTS HAVING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16710572 ↗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 INSTRUMENT WAS BROKEN/CRACKED NEXT TO THE HOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16688606 ↗MalfunctionJan 29, 2023Break; Break
IT WAS REPORTED THAT THESE ITEMS BROKE WHILE IMPLANTING, THE TECH NOTICED 7 RIGHT TRIAL WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261828 ↗MalfunctionAug 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT METAL RING CAME OUT OF POLY TRIAL. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15261826 ↗MalfunctionJun 17, 2022Break; Break
SHIM IS BROKEN. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14734875 ↗
Other TEMPLATE devices
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- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
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- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- 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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