Humeral Cup Stability 104-1006Recalls & reported problems
Fx Solutions · HUMERAL CUP STABILITY PE/TA6V Ø40/+6 · Class 2 · Implant
All models of Humeral Cup Stability (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03701037309452), received between Aug 30, 2021 and Dec 31, 2025 — classified as 8 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 Dislocation3
- Implant Pain2
- Joint Laxity2
- Insufficient Information1
Recent adverse event reports
The 8 most recent of 8 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 9 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO PAIN AT THE IMPLANT SITE. A 40 MM + 6 HUMERAL STABILITY CUP WAS EXPLANTED. THIS ITEM WAS REPLACED WITH A 40 MM + 9 HUMERAL STABILITY CUP.
Patient problems: Implant Pain
MAUDE report 23935690 ↗InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 23 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. A 40 MM + 6 HUMERAL STABILITY CUP WAS EXPLANTED. THIS ITEM WAS REPLACED WITH A 40 MM + 3 135/145* STANDARD HUMERAL CUP AND 2 OF 9 MM SPACERS.
Patient problems: Joint Dislocation
MAUDE report 23760352 ↗InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 16 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO PAIN AT THE IMPLANT SITE. A 40 MM + 6 HUMERAL STABILITY CUP WAS EXPLANTED. THIS ITEM WAS REPLACED WITH A 40 MM + 3 135/145 HUMERAL STABILITY CUP AND A 9 MM SPACER.
Patient problems: Implant Pain
MAUDE report 23324705 ↗InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED AFTER APPROXIMATELY 6 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. 40 MM + 6 HUMERAL STABILITY CUP WAS EXPLANTED AND REPLACED WITH A 40 MM + 6 135/145 HUMERAL STABILITY CUP AND 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 22107654 ↗InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 3 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 + 6 HUMERAL STABILITY CUP EXPLANTED AND REPLACED WITH 40 MM + 9 HUMERAL STABILITY CUP.
Patient problems: Joint Dislocation
MAUDE report 19984303 ↗InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISMANTLING ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2022. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 19031609 ↗InjuryAug 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO DISMANTLING ON (B)(6) 2023. THE IMPLANTATION DATE UNKNOWN . A CUP MAY BE EXPLANTED. A CUP AND A REVERSED ADAPTER WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 17555197 ↗InjuryAug 30, 2021Appropriate Device Problem Term/Code Not Available
PATIENT REVISED FOR SECOND TIME ON (B)(6) 2021. PRIMARY SURGERY ON (B)(6) 2021, AND FIRST REVISION ON (B)(6) 2021 (PREVIOUSLY REPORTED). SURGEON EXPLANTED THE 40/+6 STABILITY HUMERAL CUP AND IMPLANTED A LARGER 40/+9 STABILITY HUMERAL CUP.
Patient problems: Insufficient Information
MAUDE report 12382654 ↗
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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