NA 2294-54-100Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION SLEEVE TRIAL 37mm · 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 10603295113867), received between Mar 12, 2019 and Dec 3, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility4
- Difficult to Remove1
- 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 3, 2024Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT A KNEE REVISION WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20833631 ↗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 12042188 ↗MalfunctionApr 16, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SIZE 5 MBT TRIAL AND 37MM MBT SLEEVE TRIAL BECAME STUCK TOGETHER DURING FINAL TRIALING OF A KNEE REVISION. THEY COULD NOT BE SEPARATED IN CPD POST OPERATIVELY. NO DELAY OR ADVERSE EVENT WAS CREATED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9969945 ↗MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT WAS "UNSTICK".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9241396 ↗MalfunctionMar 12, 2019Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE TIBIAL TRAY AND SLEEVE STUCK TOGETHER. DID NOT IMPACT THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8413526 ↗
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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