NA 2294-35-120Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION TRAY TRIAL W/STEM SIZE 2 · 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 10603295113423), received between Sep 15, 2017 and Sep 5, 2018 — classified as 5 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.
Most reported problems
Device problems
- Break1
- Connection Problem1
- Device-Device Incompatibility1
- Difficult to Remove1
- Loose or Intermittent Connection1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient4
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2018Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SLEEVE AND TRAY TRIAL WERE JAMMED WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7846220 ↗MalfunctionApr 6, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE O RING WAS DAMAGED. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7402927 ↗MalfunctionApr 6, 2018Break; Break
CSR REPORTED DAMAGED MBT SIZE 2 TRIAL, PLEASE SHIP ON PO (B)(4). PATIENT CONSEQUENCE? : NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7402245 ↗MalfunctionMar 8, 2018Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT KNEE REVISION WAS PERFORMED ON (B)(6) 2018 AT (B)(6). UPON INSPECTION OF THE INSTRUMENTS ON (B)(6) 2018 THE FOLLOWING INSTRUMENTS COULDN'T BE SEPARATED AFTER CLEANING AND STERILIZATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7323657 ↗MalfunctionSep 15, 2017Loose or Intermittent Connection; Connection Problem; Loose or Intermittent Connection; Connection Problem
IT WAS REPORTED THAT TIBIAL TRAIL DOES NOT LOCK ONTO TIBIAL HANDLE WHILE THE SCRUBTECH WAS TRYING TO PIECE THE TRIALS TOGETHER.
Patient problems: No Information
MAUDE report 6868273 ↗
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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