SIGMA 2024-85-004Recalls & reported problems
Depuy (Ireland) · SIGMA HP PARTIAL KNEE-TROCHLEA BONE FILE · Class 1
All models of SIGMA (380)
Data updated Oct 16, 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 10603295084068), received between Aug 16, 2022 and Aug 16, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.
Most reported problems
Device problems
- Material Deformation1
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.
MalfunctionAug 16, 2022Material Deformation; Material Deformation
IT WAS REPORTED THE PLATE ON THE FEMORAL IMPACTOR HAS BECOME LOOSE. THE BARREL INSIDE OF THE IMPACTOR IS LOOSE. THE HANDLE ON THE KNEE BONE FILE IS BENT. NO SURGICAL DELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15232617 ↗
Other FILE devices
- P.F.C. 86-4348Depuy (Ireland) · FILE8 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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