FX V135 Shoulder Prosthesis 204-0803Recalls & reported problems
Fx Solutions · FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +3 · Class 2 · Implant
Data updated Oct 16, 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 03701037315330), received between Nov 4, 2025 and Dec 31, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Joint Dislocation1
- Joint Laxity1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 31, 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 40 MM + 3 135/145* STANDARD HUMERAL CUP WAS EXPLANTED. THIS ITEM WAS REPLACED WITH A 40 MM + 9 HUMERAL STABILITY CUP.
Patient problems: Joint Dislocation
MAUDE report 23935691 ↗InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 7 DAYS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INSTABILITY OF THE JOINT. A 40 MM + 3 135/145 HUMERAL STABILITY CUP WAS EXPLANTED. THIS ITEM WAS REPLACED WITH A 40 MM + 9 135/145 HUMERAL STABILITY CUP.
Patient problems: Joint Laxity
MAUDE report 23466213 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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