FX V 135 stem 318-5414Recalls & reported problems
Fx Solutions · FX V135 STEM TA6V Ø36/14 LG 120MM 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 03701037317938), received between Nov 8, 2024 and Nov 8, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Lack of Effect” (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
- Lack of Effect1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2024Lack of Effect; Lack of Effect
REVISION OCCURRED APPROXIMATELY 3 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. PRIOR REVISIONS HAD BEEN PERFORMED NOT INVOLVING FX. REVISION OCCURRED DUE TO PAIN FOLLOWING FAILURE OF ALLOGRAFT PROSTHESIS COMPOSITE. 36/14 120 MM SYSTEM STEM AND 40 MM + 9 HUMERAL STABILITY CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 32/08 180 MM SYSTEM STEM, 49 MM + 3 HUMERAL STABILITY CUP, AND 4 CORTICAL SCREWS.
Patient problems: Implant Pain
MAUDE report 20645374 ↗
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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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