FX V135 Shoulder Prosthesis 204-0906Recalls & reported problems
Fx Solutions · FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +6 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03701037315439), received between Feb 16, 2024 and Oct 24, 2025 — classified as 3 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 Problem3
Patient problems
- Joint Dislocation3
Recent adverse event reports
The 3 most recent of 3 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 7 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 40 MM + 6 135/145* HUMERAL STABILITY CUP WAS EXPLANTED. THIS ITEM WAS REPLACED WITH 40 MM + 9 135/145* HUMERAL STABILITY CUP.
Patient problems: Joint Dislocation
MAUDE report 23380650 ↗InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 2 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2022. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. 40 MM + 6 STABILITY HUMERAL CUP EXPLANTED AND REPLACED WITH 40 MM + 9 HUMERAL STABILITY CUP WITH 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 18987027 ↗InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 6 WEEKS AFTER THE PRIOR REVISION SURGERY WHICH OCCURRED ON (B)(6) 2023. THIS WAS PRECEDED BY THE PRIMARY SURGERY ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED FOR DISLOCATION OF UNKNOWN CAUSE. REVISION WAS A TOTAL EXPLANT OF AN FX SYSTEM WITH REPLACEMENT BY A COMPETITOR SYSTEM. EXPLANT INCLUDES: 40 MM + 6 STABILITY HUMERAL CUP, 40 MM CENTERED GLENOSPHERE, 9 MM SPACER, 24 MM CEMENTLESS BASEPLATE, 36/16 SYSTEM STEM, 20 MM CENTRAL SCREW, 30 MM STANDARD SCREW, 20 MM LOCKING SCREW (2), AND 30 MM LOCKING SCREW.
Patient problems: Joint Dislocation
MAUDE report 18721748 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- 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
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- 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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