NA 2294-54-000Recalls & reported problems
Depuy (Ireland) · M.B.T. TRAY SLEEVE TRIAL 29mm · 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 10603295113850), received between Mar 16, 2018 and Dec 2, 2022 — 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.
Most reported problems
Device problems
- Device-Device Incompatibility3
- Difficult to Remove1
- Material Deformation1
- Material Twisted/Bent1
- Naturally Worn1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE 29MM MBT REVISION SLEEVE TRIAL DOES NOT PROPERLY FIT ON THE MBT REV TIBIAL TRAY TRIAL. SEEMS TO HAVE BEEN DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15904314 ↗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 12042174 ↗MalfunctionApr 5, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE METAPHYSEAL SLEEVE TRIAL WOULD NOT SEPARATED FROM THE MBT REVISION TRAY TRIAL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8486496 ↗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 7846264 ↗MalfunctionMar 16, 2018Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT KNEE REVISION WAS PERFORMED ON (B)(6) 2018. UPON INSPECTION OF THE INSTRUMENTS ON FEBRUARY 21, 2018, THE FOLLOWING INSTRUMENTS COULDN'T BE SEPARATED AFTER CLEANING AND STERILIZATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7346598 ↗
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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