Humeral Cup Stability 104-1003Recalls & reported problems
Fx Solutions · HUMERAL CUP STABILITY PE/TA6V Ø40/+3 · Class 2 · Implant
All models of Humeral Cup Stability (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03701037309445), received between Mar 3, 2022 and Apr 13, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Adverse Event Without Identified Device or Use Problem6
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation6
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED ON (B)(6) 2026, APPROXIMATELY 313 DAYS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. BASED ON COMPARING USAGE FORMS ONLY HUMERAL CUP STABILITY PE/TA6V Ø40/+3 WAS EXPLANTED DUE TO DISLOCATION. THESE PARTS WERE REPLACED WITH HUMERAL CUP STABILITY PE/TA6V Ø40/+3 AND HUMERAL SPACER TA6V +9MM. FX V135® HUMELOCK STEM TA6V Ø40/14 LG 120MM CEMENTLESS TI/HA WAS NOT REPLACED.
Patient problems: Joint Dislocation
MAUDE report 24865931 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
SECOND REVISION OCCURRED ON (B)(6) 2026, APPROXIMATELY 21 DAYS AFTER THE FIRST REVISION SURGERY WHICH OCCURRED ON (B)(6) 2026. NO FALL OR OTHER TRAUMA REPORTED. BASED ON COMPARING USAGE FORMS ONLY HUMERAL CUP STABILITY PE/TA6V Ø40/+3 AND HUMERAL SPACER TA6V +9MM WAS EXPLANTED DUE TO DISLOCATION OF UNKNOWN CAUSE. THESE PARTS WERE REPLACED WITH HUMERAL CUP STABILITY PE/TA6V Ø40/+9 AND HUMERAL SPACER TA6V +9MM.
Patient problems: Joint Dislocation
MAUDE report 24802256 ↗InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 16 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 HUMERAL STABILITY CUP WAS EXPLANTED; THIS ITEM WAS REPLACED WITH A 40 MM + 9 135/145* HUMERAL STABILITY CUP.
Patient problems: Joint Dislocation
MAUDE report 23716756 ↗InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP WAS EXPLANTED. A CUP AND A HUMERAL SPACER WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 21418960 ↗InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 10 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. 40 MM + 3 HUMERAL STABILITY CUP EXPLANTED AND REPLACED WITH A 40 MM + 6 HUMERAL STABILITY CUP AND 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 21055600 ↗InjuryJul 25, 2024Adverse 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) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED FOR A DISLOCATION OF UNKNOWN CAUSE. THE PATIENT WAS NOT AWARE HE HAD DISLOCATED, IT WAS DISCOVERED DURING A FOLLOW-UP X-RAY. 40 MM + 3 HUMERAL STABILITY CUP EXPLANTED AND REPLACED WITH A 40 MM + 6 HUMERAL STABILITY CUP.
Patient problems: Joint Dislocation
MAUDE report 19828252 ↗InjuryMar 3, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED FOR DISLOCATION ON (B)(6) 2022. APPROXIMATELY 25 WEEKS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP STABILITY 40+3. THE SURGEON IMPLANTED 1 HUMERAL CUP STABILITY 36+3.
Patient problems: Insufficient Information
MAUDE report 13657950 ↗
Other Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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