SIGMA 2011-03-070Recalls & reported problems
Depuy (Ireland) · SIGMA HP REVISION INSTRUMENTS TC3 RP INSERT TRIAL & SPACER BLOCK CASE · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295327196), received between Sep 1, 2017 and Oct 9, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Connection Problem1
- Delamination1
- Device-Device Incompatibility1
- Difficult to Remove1
Patient problems
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 9, 2019Difficult to Remove; Connection Problem; Device-Device Incompatibility; Difficult to Remove; Connection Problem; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT PAN / LID NO LONGER FIT TOGETHER DUE TO MULTIPLE SHIPPING WITHIN TERRITORY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9171940 ↗MalfunctionSep 1, 2017Delamination; Delamination
IT WAS REPORTED THAT TRAY IS PEELING, OFFICE SET.
Patient problems: No Information
MAUDE report 6837747 ↗
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- ATTUNE 2545-01-703Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT62 reports
- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- INSTRUMENT 6541-9-109Howmedica Osteonics Corp. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6805Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501CECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 11580AKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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