ATTUNE 2545-00-930Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL SHIM SIZE 5 14mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE conventional shim, a small metal spacer used in joint replacement surgery, is the subject of 38 reports since 2017. The reports describe shims breaking, cracking, or bending, most often found cracked or snapped in two during sterilization processing or while inspecting supply trays, with the silver ring popping out in one case. None describe injury to a patient, and 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
- 38
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10603295135074), received between Nov 9, 2017 and May 1, 2026 — classified as 38 malfunctions.
The most frequently reported specific device problem is “Break” (31 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.
Reports received per month
Most reported problems
Device problems
- Break31
- Crack7
- Detachment of Device or Device Component2
- Material Twisted/Bent1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Consequences Or Impact To Patient18
- No Code Available3
- Insufficient Information1
- No Information1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT IN STERILE PROCESSING A SIZE 5/6 14 MM SHIM BROKE INTO TWO PIECES. THE BREAK HAD NOT OCCURRED DURING THE SURGERY, SO THERE WERE NO DELAYS, COMPLICATIONS, OR BROKEN PIECES TO RETRIEVE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059728 ↗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 23583442 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTED PRODUCTS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437345 ↗MalfunctionApr 30, 2025Break; Break
IT WAS REPORTED THAT AN ATTUNE SHIM WAS FOUND BROKEN IN THE PC BOX AT THE HOSPITAL.
Patient problems: Insufficient Information
MAUDE report 21937504 ↗MalfunctionMar 5, 2025Break; Break
IT WAS REPORTED THAT THE SZ 5-6 14MM SHIM WAS BROKEN IN TWO PIECES. THE SHIM FOUND BROKEN AT THE START OF THE CASE AND WAS NOT USED IN SURGERY. THERE WAS NO PATIENT IMPACT AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21528643 ↗MalfunctionFeb 5, 2025Break; Break
IT WAS REPORTED THAT DURING MDRD INSPECTION, THE DEVICE WAS FOUND TO BE BROKEN AND NO LONGER SUITABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21312406 ↗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 18857067 ↗MalfunctionJan 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SILVER RING POPPED OUT FROM ATTUNE 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. 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 18474756 ↗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 18464311 ↗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 17009837 ↗MalfunctionMay 26, 2023Break; Break
IT WAS REPORTED THAT DEVICE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17009799 ↗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 17009782 ↗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 16843242 ↗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 16275059 ↗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 16274940 ↗MalfunctionSep 16, 2022Break; Break
IT WAS REPORTED AS A LIST OF BROKEN INSTRUMENTS THAT HAVE BEEN COLLECTED IN CSSD OVER COURSE OF THE WEEK. INSTRUMENTS ARE ALL FROM CONSIGNMENT SETS. THE LIST CONTAINS MATERIAL ITEM NUMBERS BUT NO DESCRIPTION AS TO HOW THEY BROKE OR THE EXTENT OF THEIR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15438457 ↗MalfunctionSep 17, 2021Break; Break
IT WAS REPORTED THAT THE ARTICULATING SURFACE REMAINS INTACT WITH THE SPRING AROUND THE CONNECTION NODE HAS COME LOOSE. THE FEMORAL IMPACTOR IS ALSO IN 2 PIECES WITH ALL PARTS RETAINED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12487484 ↗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 12005076 ↗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 11166740 ↗MalfunctionNov 17, 2020Break; Break
INFORMED BY CSSD DEPARTMENT THAT THEY HAD FOUND BROKEN INSTRUMENTS FOLLOWING THE CLEANING, AND STERILIZATION PROCESS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10854115 ↗MalfunctionOct 22, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTRUMENT BROKE INTO 2 OR MORE PIECES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10721545 ↗MalfunctionSep 24, 2020Break; Break
BROKEN ATTUNE INSTRUMENTS REPORTED BY (B)(6) STAFF. NO REPORT OF SURGICAL DELAY OR PATIENT CONSEQUENCES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10584287 ↗MalfunctionSep 9, 2020Crack; Crack
IT WAS REPORTED THAT PRIOR TO STERILIZATION WHILE INSPECTING INSTRUMENTS, NOTICED THE ATTUNE TRIAL EXTRACTOR WAS WORN DOWN AND 2 SHIMS HAD CRACKED. THESE WERE NOT USED IN SURGERY AND SURGERY WAS NOT DELAYED. DOE: (B)(6) 2020.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10510297 ↗MalfunctionAug 25, 2020Break; Break
BROKEN ATTUNE SHIM AND IMPACTOR. BROKEN AND WORN SROM OSTEOTOME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10448488 ↗MalfunctionAug 24, 2020Break; Break
IT WAS REPORTED THAT WHILE EXTRACTING TRIAL POLY (SHIM + ARTICULATING SURFACE), THE SHIM BROKE AT THE BULLET CONNECTION SPOT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10442146 ↗
Other TEMPLATE devices
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- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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