NA 2294-35-125Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION TRAY TRIAL W/STEM SIZE 2.5 · 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 10603295113430), received between Sep 7, 2017 and Jun 22, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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.
Most reported problems
Device problems
- Device-Device Incompatibility2
- Break1
- Component Missing1
- Crack1
- Detachment Of Device Component1
- Failure to Disconnect1
- Material Twisted/Bent1
- Naturally Worn1
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.
MalfunctionJun 22, 2021Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT DURING A COMPLEX KNEE USING THE TC3 AND REVISION MBT SYSTEM THE SLEEVE TRIALS ARE NOT CONNECTING TO THE TRAY TRIALS. SURGEON FEELS THE SET IS WORN OUT, TOO OLD AND THE TRIALS NEED TO BE REPLACED. REQUESTED ALL SIZES TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12042032 ↗MalfunctionMay 12, 2021Crack; Crack
EMAIL RECEIVED FROM CSSD DEPARTMENT AT (B)(6) HOSPITAL WITH A LIST OF BROKEN INSTRUMENTS. ALL INSTRUMENTS REMAIN IN ONE PIECE. INSTRUMENTS HAVE BEEN RECEIVED AND INVESTIGATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11811661 ↗MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility
MalfunctionMar 13, 2019Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED THAT THE TIBIAL TRAY AND SLEEVE STUCK TOGETHER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8416113 ↗MalfunctionSep 7, 2017Break; Detachment Of Device Component; Component Missing; Break; Detachment Of Device Component; Component Missing
IT WAS REPORTED THAT THE ORANGE RING WAS NOT PRESENT. STEM WOULD NOT STAY CONNECTED TO MBT REVISION TRAY.
Patient problems: No Information
MAUDE report 6849590 ↗
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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