Humeral Cup Stability 314-0909Recalls & reported problems
Fx Solutions · HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03701037310519), received between Feb 7, 2022 and Dec 2, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Unstable” (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 Problem2
- Appropriate Device Problem Term/Code Not Available1
- Unstable1
Patient problems
- Damage to Ligament(s)1
- Insufficient Information1
- Joint Laxity1
- Medical device site infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO GLÉNOSPHÈRE DÉSASSEMBLY ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2021. A CUP, A GLENOSPHERE, AND A METAGLENE WERE EXPLANTED. AN HELMET HEAD AND A DOUBLE TAPER WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 20817109 ↗InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2014. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS, A SMARTLOOP AND A STEM WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 18765493 ↗InjuryApr 13, 2023Unstable; Unstable
THE PATIENT WAS REVISED DUE TO SHOULDER INSTABILITY ON (B)(6) 2022. THE IMPLANTATION DATE WAS ON (B)(6) 2022. A CEMENTELESS GLENOID BASEPLANE AND A HUMARAL CUP WERE EXPLANTED. A CENTRED GLENOSPHERE, A HUMERAL CUP, CEMENTELESS GLENOIDE BASEPLATE WERE IMPLANTED.
Patient problems: Damage to Ligament(s)
MAUDE report 16731428 ↗InjuryFeb 7, 2022Appropriate Device Problem Term/Code Not Available
PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INSTABILITY. APPROXIMATELY 136 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED Ø40+9 STABILITY CUP, CENTERED GLENOSPHERE AND ANCHOR BASE. THE SURGEON IMPLANTED Ø 40+9 STABILITY CUP, ECCENTERED GLENOSPHERE, HUMERAL SPACER AND Ø 36/14 STEM.
Patient problems: Insufficient Information
MAUDE report 13470426 ↗
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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