Humeral Cup Stability 313-0903Recalls & reported problems
Fx Solutions · HUMERAL CUP 135/145° STABILITY PE/TA6V Ø36 +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
- 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 03701037310526), received between Dec 3, 2021 and Oct 17, 2023 — classified as 6 injuries.
The most frequently reported specific device problem is “Break” (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
- Appropriate Device Problem Term/Code Not Available2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Device Dislodged or Dislocated1
- Microbial Contamination of Device1
- Unstable1
Patient problems
- Insufficient Information2
- Joint Laxity2
- Failure of Implant1
- Medical device site infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REVISION OCCURRED ON 14-AUG-2023. CAUSE OF REVISION WAS DISLOCATION RESULTING FROM JOINT LAXITY APPROXIMATELY THREE WEEKS AFTER INITIAL IMPLANTATION DATE. NO FALL OR OTHER TRAUMA REPORTED. HUMERAL CUP 36 MM +3 EXPLANTED. THIS PART WAS REPLACED BY A REVERSE ADAPTER AND STABILITY HUMERAL CUP 36 MM +6.
Patient problems: Joint Laxity
MAUDE report 17950218 ↗InjurySep 28, 2023Microbial Contamination of Device; Microbial Contamination of Device
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 17832907 ↗InjuryJan 13, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2021, APPROXIMATELY 07 MONTHS AFTER THE PRIMARY SURGERY ON (B)(6) 2021 DUE TO DISSOCIATION OF THE HUMERAL CUP FROM THE STEM TAPER. THE HUMERAL CUP (36/3) WAS EXPLANTED AND A NEW HUMERAL CUP (36/3) WAS IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 13248062 ↗InjuryJan 4, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2021, APPROXIMATELY 07 MONTHS AFTER THE PRIMARY SURGERY ON (B)(6) 2021 DUE TO DISSOCIATION OF THE HUMERAL CUP FROM THE STEM TAPER. THE HUMERAL CUP (36/3) WAS EXPLANTED AND A NEW HUMERAL CUP (36/3) WAS IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 13158479 ↗InjuryDec 15, 2021Break
THE PATIENT WAS REVISED ON (B)(6) 2021, APPROXIMATELY 6 WEEKS AFTER THE PRIMARY SURGERY ON (B)(6) 2021 AS THE HUMERAL CUP POPPED OFF (DISENGAGED). THE HUMERAL CUP (36/3) AND HUMERIS STEM CEMENTLESS (16) WERE EXPLANTED AND A HUMERAL CUP (36/3) AND HUMERIS STEM CEMENTLESS (18) WERE IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13012493 ↗InjuryDec 3, 2021Unstable
PATIENT REVISED ON (B)(6) 2021 DUE TO INSTABILITY, APPROXIMATELY 4.5 MONTHS FOLLOWING PRIMARY SURGERY ON (B)(6) 2021. SURGEON EXPLANTED THE 135/145 36/+3 STABILITY HUMERAL CUP AND REPLACED IT WITH A 36/+6 STABILITY HUMERAL CUP AND A 135/145 REVERSED ADAPTER FOR AN EXTRA +9MM OF SPACING.
Patient problems: Joint Laxity
MAUDE report 12923438 ↗
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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