FX V 135 stem 318-5410Recalls & reported problems
Fx Solutions · FX V135 STEM TA6V Ø36/10 LG 120MM CEMENTLESS Ti/HA · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03701037317914), received between Aug 27, 2025 and Oct 24, 2025 — classified as 2 injuries.
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 Problem2
Patient problems
- Joint Dislocation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 4 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. A 36/10 120 MM SYSTEM STEM, 40 MM + 3 HUMERAL STABILITY CUP, AND 9 MM SPACER WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 32/10 MINI SYSTEM STEM, 40 MM + 9 135/145* HUMERAL STABILITY CUP, AND 2 OF 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 23380652 ↗InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 2 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. A 36/10 120 MM SYSTEM STEM, 24 MM + 3 LATERALIZED BASEPLATE, 36 MM CENTERED GLENOSPHERE, 36 MM + 9 STANDARD HUMERAL CUP, 9 MM SPACER, AND 6 SCREWS WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 40/12 120 MM SYSTEM STEM, 24 MM + 6 LATERALIZED BASEPLATE, 36 MM CENTERED GLENOSPHERE, 36 MM + 9 STANDARD HUMERAL CUP, AND 6 SCREWS.
Patient problems: Joint Dislocation
MAUDE report 22906975 ↗
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- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
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- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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