NA 2294-36-125Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION TRAY TRIAL SIZE 2.5 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295113539), received between Aug 25, 2017 and Aug 7, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Disassembly” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Disassembly1
- Material Deformation1
- Naturally Worn1
Patient problems
- No Consequences Or Impact To Patient2
- No Code Available1
- No Information1
- Not Applicable1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THERE WAS A BURR ON PIN HOLE IN TIBIAL TRAY TRIAL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7757053 ↗MalfunctionMay 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING THE CASE, A FEW OF THE TRIALS USED DID NOT EFFECTIVELY HOLD ONTO THE STEM TRIALS. THIS DID NOT CREATE ANY MAJOR DELAYS HOWEVER TWICE THE STEM TRIAL CAME LOOSE AND HAD TO BE RETRIEVED FROM THE PATIENT'S TIBIA. FOLLOWING THE CASE, I TESTED THESE TRIALS AND BROACHES AND WILL BE RETURNING THEM TO GET NEW ONES. THE RUBBER GASKET ARE GETTING WORN OUT. THERE WAS A SURGICAL DELAY OF 5 MINUTES.
Patient problems: No Code Available; Not Applicable
MAUDE report 7479321 ↗MalfunctionApr 16, 2018Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE MBT REVISION TRIAL SIZE 2/2.5/3/4/5 INNER STEM BUSHING IS WORN OUT AND WILL NO LONGER KEEP STEM TRIAL IN ATTACHMENT. NEEDS REPLACEMENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7432368 ↗MalfunctionAug 25, 2017Disassembly; Disassembly
IT WAS REPORTED THAT THE PINS COLD WELDED TO ALL 3 TRAY PIN HOLES. IT WAS ALSO REPORTED THAT THE PINS WERE REMOVED FROM THE TRAYS AFTER THE CASE.
Patient problems: No Information
MAUDE report 6821572 ↗
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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