Humeral Cup Stability 103-1009Recalls & reported problems
Fx Solutions · HUMERAL CUP STABILITY PE/TA6V Ø36/+9 · 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 03701037309438), received between Dec 27, 2021 and May 1, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Unstable” (2 reports).
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
- Appropriate Device Problem Term/Code Not Available3
- Adverse Event Without Identified Device or Use Problem2
- Unstable2
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation3
- Subluxation2
- Fall1
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED ON (B)(6) 2026, APPROXIMATELY 126 DAYS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. HUMERAL CUP STABILITY PE/TA6V Ø36/+9 AND HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW COCR/TA6V 10° TILT Ø36MM WAS EXPLANTED DUE TO DISLOCATION. THESE PARTS WERE REPLACED WITH FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø36 +3, HUMERAL SPACER TA6V +9MM AND HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW COCR/TA6V 10° TILT Ø36MM. FX V135® HUMELOCK STEM TA6V Ø36/14 L. 120MM CEMENTLESS TI/HA WAS NOT REPLACED.
Patient problems: Joint Dislocation
MAUDE report 25060146 ↗InjuryNov 14, 2023Adverse 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) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 18128679 ↗InjuryOct 10, 2023Unstable; Unstable
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP AND A HUMERAL SPACER WERE EXPLANTED. A CUP AND A HUMERAL SPACER WERE IMPLANTED.
Patient problems: Subluxation
MAUDE report 17904813 ↗InjuryMay 23, 2023Unstable; Unstable
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2022. A CUP WAS EXPLANTED. A HEAD AND AN ECCENTRIC TAPER ADAPTER WERE IMPLANTED.
Patient problems: Subluxation
MAUDE report 16982256 ↗InjuryMar 3, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 FOR DISLOCATION. APPROXIMATELY 10 WEEKS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP (36/9), 1 HUMERAL SPACER (9) AND 1 HUMELOCK REVERSED STEM (31/10). THE SURGEON IMPLANTED 1 ECCENTRIC TAPER ADAPTER (24/10) AND 1 OFFSET COCR HEAD.
Patient problems: Joint Dislocation
MAUDE report 13657980 ↗InjuryJan 25, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED THE SECOND TIME ON (B)(6) 2022, FOLLOWING THE FIRST REVISION ON (B)(6) 2021 (REPORTED UNDER MDR 3014128390-2021-00054) AND PRIMARY SURGERY ON (B)(6) 2021 DUE TO CHRONIC DISLOCATION. THE SURGEON EXPLANTED THE HUMERAL CUP (36/9) AND HUMERAL SPACER (9) AND IMPLANTED AN ECCENTRIC ADAPTER (24/10) AND OFFSET COCR HEAD (41X16).
Patient problems: Insufficient Information
MAUDE report 13347677 ↗InjuryDec 27, 2021Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED FOR A SECOND TIME ON (B)(6) 2021 AFTER INITIAL REVISION SURGERY ON (B)(6) 2021 AND THE PRIMARY SURGERY ON (B)(6) 2021 DUE TO FALL. THE HUMERAL CUP (36/9) WAS EXPLANTED. A HUMERAL CUP (36/3) AND HUMERAL SPACER (9MM) WAS IMPLANTED.
Patient problems: Fall
MAUDE report 13090592 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page