FX V135 318-3212Recalls & reported problems
FX Shoulder Solutions, Inc. · FX V135 STEM TA6V Ø32/12 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 00840452403642), received between May 4, 2026 and May 4, 2026 — 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.
InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
SECOND REVISION OCCURRED ON (B)(6) 2026, APPROXIMATELY 10 MONTHS AFTER THE FIRST REVISION IN (B)(6) 2025. THE PRIMARY SURGERY HAPPENED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. BASED ON COMPARING USAGE FORMS FX V135 STEM TA6V Ø32/12 CEMENTLESS TI/HA, HUMERAL CUP STANDARD PE/TA6V Ø36/+3, HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V 10° TILT Ø36MM, HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASEPLATE W/ SCREW TI/HA Ø24MM, +3MM LATERALIZED, CENTRAL SCREW TA6V Ø4.5MM L.20MM, STANDARD SCREW TA6V Ø4.5MM L.20MM, STANDARD SCREW TA6V Ø4.5MM L.35MM AND TWO LOCKING SCREW TA6V Ø4.5MM L.35MM WAS EXPLANTED IN MAY 2025 DUE TO INFECTION AND REPLACED WITH ANTIBIOTIC SPACER. THE ANTIBIOTIC SPACER WAS EXPLANTED, AND REPLACED WITH FX V135® HUMELOCK STEM TA6V Ø32/10 L. 120MM CEMENTLESS TI/HA, HUMERAL CUP STABILITY PE/TA6V Ø36/+3, HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V 10° TILT Ø36MM, HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASEPLATE W/PEG TI/HA Ø24MM, +3MM LATERALIZED, POST EXTENSION TA6V +06MM CEMENTLESS TI/HA, LOCKING SCREW TA6V Ø4.5MM L.15MM, LOCKING SCREW TA6V Ø4.5MM L.30MM, STANDARD SCREW TA6V Ø4.5MM L.30MM, CORTICAL SCREW TA6V Ø4.5MM L.28MM AND CORTICAL SC
Patient problems: Medical device site infection
MAUDE report 25070409 ↗
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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