NA 2004-20-923Recalls & reported problems
Depuy (Ireland) · TIBIA EXTENSION · Class 1
Data updated Oct 16, 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 10603295081043), received between Nov 5, 2018 and Jun 8, 2023 — 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 16, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility4
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRUMATCH TIBIAL PIN GUIDE DID NOT ATTACH TO THE TIBIAL UPROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17087594 ↗MalfunctionJun 8, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRUMATCH TIBIAL PIN GUIDE DID NOT ATTACH TO THE TIBIAL UPROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17087532 ↗MalfunctionJun 8, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRUMATCH TIBIAL PIN GUIDE DID NOT ATTACH TO THE TIBIAL UPROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17087531 ↗MalfunctionJun 8, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRUMATCH TIBIAL PIN GUIDE DID NOT ATTACH TO THE TIBIAL UPROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17087521 ↗MalfunctionNov 5, 2018Break; Break
IT WAS REPORTED THAT THE SPRING BROKE PRIOR TO SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8037686 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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