NA 2294-53-120Recalls & reported problems
Depuy (Ireland) · UNIVERSAL REVISION FEMORAL SLEEVE TRIAL 34mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295113744), received between Aug 18, 2017 and May 16, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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
- Device-Device Incompatibility3
- Break1
- Component Missing1
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Break; Break
IT WAS REPORTED THE RUBBER SEALS ON SEVERAL TRIALS WERE TORN. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22036400 ↗MalfunctionJan 20, 2022Device-Device Incompatibility; Device-Device Incompatibility
THE 2 INSTRUMENTS GOT STUCK TOGETHER AND COULDN¿T BE SEPARATED AT THE END OF SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13310840 ↗MalfunctionJun 17, 2019Connection Problem; Device-Device Incompatibility; Connection Problem; Device-Device Incompatibility
PATIENT STEM TRIAL EXTRACTOR WAS BENT AND BROKE WHEN USED ON THE PATIENT. 34MM FEMORAL SLEEVE TRIAL THREAD WAS DAMAGED AND COULDN'T ATTACH TO THE FEMORAL TRIAL COMPONENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8703590 ↗MalfunctionAug 30, 2018Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE METAL NEEDS TO BE SANDED DOWN. IT WAS AN OFFICE SET. DID NOT EFFECT SURGERY. INABILITY TO DISASSEMBLE MATING DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7832391 ↗MalfunctionAug 18, 2017Component Missing; Component Missing
IT WAS REPORTED THAT THE FEMORAL SLEEVE TRIAL - STEM LOOSE ON IT DURING AN INSERVICE.
Patient problems: No Information
MAUDE report 6805135 ↗
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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