Humeral Cup Stability 104-1009Recalls & reported problems
Fx Solutions · HUMERAL CUP 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03701037309469), received between Apr 5, 2022 and Dec 12, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 Problem4
- Appropriate Device Problem Term/Code Not Available1
- Improper or Incorrect Procedure or Method1
Patient problems
- Joint Dislocation3
- Inadequate Osseointegration1
- Medical device site infection1
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
REVISION OCCURRED APPROXIMATELY 8 DAYS AFTER THE PRIOR REVISION SURGERY, WHICH OCCURRED ON (B)(6) 2025 AND WAS RECORDED IN PER 25-805. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO USER ERROR. ACCORDING TO THE DISTRIBUTOR, THE SURGEON DID NOT FOLLOW THE SURGICAL TECHNIQUE: HE DID NOT LINE UP THE HUMERAL CUP IMPACTOR AND IMPACTED FROM AN OBLIQUE ANGLE, RESULTING IN THE DISSOCIATION OF THE HUMERAL SPACER FROM THE STEM. A 40 MM + 9 HUMERAL STABILITY CUP AND 9 MM SPACER WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH IDENTICAL COMPONENTS.
Patient problems: Inadequate Osseointegration
MAUDE report 23791417 ↗InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 14 DAYS 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 + 9 HUMERAL STABILITY CUP WAS EXPLANTED. THIS ITEM WAS REPLACED WITH A 40 MM + 6 HUMERAL STABILITY CUP AND A 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 23314056 ↗InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 3 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON 22-MAY-2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. A 40 + 9 MM HUMERAL STABILITY CUP WAS EXPLANTED. THIS WAS REPLACED WITH A 40 MM + 3 HUMERAL STABILITY CUP, AND A 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 22346503 ↗InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 4 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 + 9 HUMERAL STABILITY CUP EXPLANTED AND REPLACED WITH A 40 MM + 9 HUMERAL STABILITY CUP AND 2 OF 9 MM SPACERS.
Patient problems: Joint Dislocation
MAUDE report 19637596 ↗InjuryApr 30, 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) 2024. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 19211821 ↗InjuryApr 5, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INFECTION. APPROXIMATELY 27 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 ECCENTRIC GLENOSPHERE, 2 LOCKING SCREW, 2 STANDARD SCREW, 2 CORTICAL SCREW ANS 1 HUMERAL CUP STABILITY Ø40+9. THE SURGEON IMPLANTED 1 HELEMET HEAD AND 1 OFFSET TAPER ADAPTER.
Patient problems: Unspecified Infection
MAUDE report 14010466 ↗
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