SIGMA 2024-44-111Recalls & reported problems
Depuy (Ireland) · SIGMA HP PARTIAL KNEE UNI STERILE CASE 1 · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295083115), received between Jun 26, 2017 and Jun 26, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Flaked” (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
- Flaked1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2017Flaked; Flaked
THE BLACK PAINT OF 2 BASKETS IS REMOVED DURING THE STERILIZATION AND MIXES WITH THE INSTRUMENTS.
Patient problems: No Information
MAUDE report 6666645 ↗
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- n.a. 39501CECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.