Sigma Hip Revision Sleeve Extraction Case 84-1980Recalls & reported problems
Symmetry Medical Inc. · Sigma Hip Revision Sleeve Extraction Case · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00847538008661), received between Jan 14, 2025 and Jan 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Peeled/Delaminated” (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. 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
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT PANS WERE FLAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21151563 ↗
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- None 400499Intuitive Surgical, Inc. · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD3-7STCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD5-3C-GREENCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD5-3C-GOLDCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD5-61C-GREENCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 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 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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