Humeral Cup StabilityRecalls & reported problems across all models
Fx Solutions · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 65
- Deaths reported
- 0
- Injuries reported
- 65
- Recalls
- 0
We found 15 models of Humeral Cup Stability by Fx Solutions in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Aug 30, 2021 and Sep 30, 2026 — classified as 65 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Humeral Cup Stability problems
Device problems
- Adverse Event Without Identified Device or Use Problem36
- Appropriate Device Problem Term/Code Not Available14
- Device Dislodged or Dislocated9
- Unstable8
- Improper or Incorrect Procedure or Method2
- Break1
- Microbial Contamination of Device1
Patient problems
- Joint Dislocation26
- Insufficient Information11
- Joint Laxity7
- Medical device site infection7
- Subluxation5
- Damage to Ligament(s)2
- Implant Pain2
- Failure of Implant1
Humeral Cup Stability models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Humeral Cup Stability 103-1003Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented10 reports
- Humeral Cup Stability 104-1006Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented8 reports
- Humeral Cup Stability 103-1009Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented7 reports
- Humeral Cup Stability 104-1003Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented7 reports
- Humeral Cup Stability 103-1006Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented6 reports
- Humeral Cup Stability 104-1009Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented6 reports
- Humeral Cup Stability 313-0903Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented6 reports
- Humeral Cup Stability 314-0909Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented4 reports
- Humeral Cup Stability 313-0909Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented3 reports
- Humeral Cup Stability 314-0906Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2 reports
- Humeral Cup Stability 312-0903Shoulder Prosthesis, Reverse Configuration2 reports
- Humeral Cup Stability 102-1003Shoulder Prosthesis, Reverse Configuration1 report
- Humeral Cup Stability 314-0903Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 report
- Humeral Cup Stability 313-0906Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 report
- Humeral Cup Stability 312-0909Shoulder Prosthesis, Reverse Configuration1 report
Recent Humeral Cup Stability adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
The patient was revised due to dislocation on (b)(6) 2026.The implantation date was on (b)(6) 2017. A glenosphere and a humeral cup were explanted. A glenosphere and a humeral cup were implanted .
Patient problems: Joint Dislocation
MAUDE report 50946797 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Dislocation
MAUDE report 50873249 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Medical device site infection
MAUDE report 50762728 ↗InjurySep 14, 2026Improper or Incorrect Procedure or Method
Revision occurred on (b)(6) 2026 approximately after 14 days after the primary surgery which happened on (b)(6) 2026. No fall or trauma was reported. Based on comparing usage forms HUMERAL CUP STABILITY PE/TA6V Ø36/+3 and FX V135 HUMERAL SPACER TA6V +9mm was explanted due to cup and spacer disassociated from stem. This part was replaced with HUMERAL CUP STANDARD PE/TA6V Ø36/+3 and HUMERAL SPACER TA6V +9mm. FX V135® HUMELOCK STEM TA6V Ø36/10 L. 120MM CEMENTLESS Ti/HAwas not replaced.
Patient problems: Joint Laxity
MAUDE report 50756685 ↗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 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED ON (B)(6) 2026, APPROXIMATELY 313 DAYS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. BASED ON COMPARING USAGE FORMS ONLY HUMERAL CUP STABILITY PE/TA6V Ø40/+3 WAS EXPLANTED DUE TO DISLOCATION. THESE PARTS WERE REPLACED WITH HUMERAL CUP STABILITY PE/TA6V Ø40/+3 AND HUMERAL SPACER TA6V +9MM. FX V135® HUMELOCK STEM TA6V Ø40/14 LG 120MM CEMENTLESS TI/HA WAS NOT REPLACED.
Patient problems: Joint Dislocation
MAUDE report 24865931 ↗InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO AN INFECTION AND INSTABILITY ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2026. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 24838598 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED ON (B)(6) 2026, APPROXIMATELY 12 DAYS AFTER THE FIRST REVISION SURGERY WHICH OCCURRED ON (B)(6) 2026. NO FALL OR OTHER TRAUMA REPORTED. BASED ON COMPARING USAGE FORMS ONLY 36MM +6 HUMERAL CUP STABILITY AND +9MM HUMERAL SPACER WAS EXPLANTED DUE TO DISLOCATION OF UNKNOWN CAUSE. THESE PARTS WERE REPLACED WITH 36MM +9HUMERAL CUP STABILITY AND +9MM HUMERAL SPACER. FX V135® HUMELOCK STEM TA6V Ø40/16 L. 120MM CEMENTLESS TI/HA WAS NOT REPLACED.
Patient problems: Joint Dislocation
MAUDE report 24810650 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
SECOND REVISION OCCURRED ON (B)(6) 2026, APPROXIMATELY 21 DAYS AFTER THE FIRST REVISION SURGERY WHICH OCCURRED ON (B)(6) 2026. NO FALL OR OTHER TRAUMA REPORTED. BASED ON COMPARING USAGE FORMS ONLY HUMERAL CUP STABILITY PE/TA6V Ø40/+3 AND HUMERAL SPACER TA6V +9MM WAS EXPLANTED DUE TO DISLOCATION OF UNKNOWN CAUSE. THESE PARTS WERE REPLACED WITH HUMERAL CUP STABILITY PE/TA6V Ø40/+9 AND HUMERAL SPACER TA6V +9MM.
Patient problems: Joint Dislocation
MAUDE report 24802256 ↗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 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 ↗InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 7 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. A 36 MM + 3 HUMERAL STABILITY CUP WAS EXPLANTED. THIS ITEM WAS REPLACED WITH A 36 MM + 9 135/145* HUMERAL STABILITY CUP.
Patient problems: Joint Dislocation
MAUDE report 23791410 ↗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 ↗InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 20 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. A 36 MM + 6 135/145 HUMERAL STABILITY CUP WAS EXPLANTED. THIS ITEM WAS REPLACED WITH A 36 MM + 3 HUMERAL STABILITY CUP AND A +9 135/145* REVERSED ADAPTER.
Patient problems: Joint Dislocation
MAUDE report 23716757 ↗InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 16 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. A 40 MM + 3 HUMERAL STABILITY CUP WAS EXPLANTED; THIS ITEM WAS REPLACED WITH A 40 MM + 9 135/145* HUMERAL STABILITY CUP.
Patient problems: Joint Dislocation
MAUDE report 23716756 ↗
Other Fx Solutions products
- Humelock II Cemented Reversible Shoulder23 models · 406 reports
- TiN Coated Glenosphere5 models · 27 reports · 1 recall
- Humelock Cemented Shoulder Prosthesis7 models · 22 reports · 1 recall
- Humeris Shoulder9 models · 35 reports
- Humelock Reversed Shoulder13 models · 32 reports
- Humelock II Cementless Shoulder System5 models · 26 reports
- Easytech Anatomical Shoulder System4 models · 24 reports
- Humelock II Cemented Shoulder System9 models · 20 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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