NA 234-020-046Recalls & reported problems
Stryker Corporation · 6MM FEMORAL AIMER · Class 1
Data updated Oct 16, 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 07613154174836), received between Dec 1, 2022 and Jan 16, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
- Material Integrity Problem1
- Product Quality Problem1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2026Material Fragmentation; Product Quality Problem
IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. BASED ON INVESTIGATION FINDINGS, THE INSERTER TIP WAS BROKEN OFF. PER ADDITIONAL INFORMATION RECEIVED, ALL PIECES WERE ABLE TO BE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 24099194 ↗MalfunctionDec 1, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15898923 ↗
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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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