FX V 135 stem 318-3614Recalls & reported problems
Fx Solutions · FX V 135 stem TA6V Ø36/14 cementless Ti/HA · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03701037315194), received between Feb 7, 2025 and Feb 7, 2025 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Medical device site infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 6 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON(B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION. 36/14 MINI SYSTEM STEM, 32 MM ECCENTRIC GLENOSPHERE, 32 MM + 9 STANDARD HUMERAL CUP, AND 3 LOCKING SCREWS EXPLANTED. THESE PARTS WERE REPLACED WITH A 36/14 MINI SYSTEM STEM, 32 MM CENTERED GLENOSPHERE, 32 MM + 3 STANDARD HUMERAL CUP, 9 MM SPACER, AND 3 SCREWS.
Patient problems: Medical device site infection
MAUDE report 21335984 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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