ATTUNE 2545-00-633Recalls & reported problems
Depuy (Ireland) · ATTUNE SHIM SIZE 3 8mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295133353), received between Sep 25, 2018 and Oct 31, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (7 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
- Break7
- Crack1
- Naturally Worn1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTED PRODUCTS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437319 ↗MalfunctionOct 29, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE EVENT OCCURRED AFTER THE CASES THAT DAY. THE DEVICE BROKE IN THE REP ROOM. HOW IT BROKE WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20556100 ↗MalfunctionApr 12, 2023Break; Break
IT WAS REPORTED THE INSTRUMENT ARE BROKEN. THERE IS NO DESCRIPTION OF HOW THE DAMAGE OCCURRED OR THE EXTENT OF THE DAMAGE. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16728972 ↗MalfunctionNov 23, 2021Break; Break
IT WAS REPORTED THAT THE SHIMS BROKE DURING TRAILING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12860923 ↗MalfunctionOct 27, 2021Break; Crack; Naturally Worn; Break; Crack; Naturally Worn
ADDITIONAL INFORMATION RECEIVED, INDICATED THAT LOT NUMBERS WORN OFF THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12703996 ↗MalfunctionMar 15, 2019Break; Break
IT WAS REPORTED THAT THE SHIM WAS BROKEN. HAD CRACKED DOWN MIDDLE. ALL PIECES WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8425496 ↗MalfunctionMar 12, 2019Break; Break
IT WAS REPORTED THAT TGE SHIM BROKE WHERE CONNECTS TO POLY TRIAL. ALL PIECES RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8413710 ↗MalfunctionSep 25, 2018Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT ATTUNE SHIMS CHIPPED AND DAMAGED FROM RETRACTORS IN SET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7908403 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- 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
- 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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