NA 2294-53-140Recalls & reported problems
Depuy (Ireland) · UNIVERSAL REVISION FEMORAL SLEEVE TRIAL 46mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295113768), received between Jan 16, 2019 and May 16, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Detachment of Device or Device Component1
- Loss of Osseointegration1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Inadequate Osseointegration1
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 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 22036412 ↗MalfunctionJul 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE 46 MM BROACH HAD NO ORANGE PLUNGER TO HOLD A STEM EXTENSION IN PLACE. THIS WAS DISCOVERED IN THE OFFICE, SO IT WAS NOT USED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12247522 ↗InjuryJan 16, 2019Loss of Osseointegration; Loss of Osseointegration
PATIENT HAD KNEE REVISION FOR LOOSE FEMORAL REVISION COMPONENT. METAPHYSEAL SLEEVE & PRESS FIT STEM WERE LOOSE. COMPONENTS WERE REMOVED & CULTURES PROVED TO BE NEGATIVE FOR INFECTION.
Patient problems: Inadequate Osseointegration; No Code Available
MAUDE report 8254356 ↗MalfunctionJan 16, 2019Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE THREADS ON BOLT AND SLEEVE ARE NON FUNCTIONAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8253124 ↗
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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