TiN Coated GlenosphereRecalls & reported problems across all models
Fx Solutions · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one TiN Coated Glenosphere model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls
- 1
We found 5 models of TiN Coated Glenosphere by Fx Solutions in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Feb 21, 2022 and Jun 23, 2026 — classified as 27 injuries.
The most frequently reported specific device problem is “Lack of Effect” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
TiN Coated Glenosphere recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 8, 2023Open, Classified
Centered glenosphere box may contain an eccentric glenosphere.
Z-0843-2024 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported TiN Coated Glenosphere problems
Device problems
- Adverse Event Without Identified Device or Use Problem25
- Appropriate Device Problem Term/Code Not Available1
- Lack of Effect1
- Material Separation1
Patient problems
- Joint Dislocation13
- Joint Laxity5
- Medical device site infection5
- Implant Pain3
- Insufficient Information1
TiN Coated Glenosphere models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TiN Coated Glenosphere 115-3210Shoulder Prosthesis, Reverse Configuration1 recall4 reports
- TiN Coated Glenosphere 115-3610Shoulder Prosthesis, Reverse Configuration17 reports
- TiN Coated Glenosphere 115-3613Shoulder Prosthesis, Reverse Configuration3 reports
- TiN Coated Glenosphere 115-4010Shoulder Prosthesis, Reverse Configuration2 reports
- TiN Coated Glenosphere 115-3211Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 report
Recent TiN Coated Glenosphere adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED ON (B)(6) 2026 APPROXIMATELY 231 DAYS AFTER THE PRIMARY WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA WAS REPORTED. BASED ON COMPARING USAGE FORMS ONLY HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TIN 10° TILT Ø32MM AND HUMERAL CUP STABILITY PE/TA6V Ø32/+9 WAS EXPLANTED DUE TO PAIN AND REPLACED WITH FX V135 HUMERAL SPACER TA6V +9MM, FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +3 AND HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TIN 10° TILT Ø40MM. FX V135 STEM TA6V Ø32/12 CEMENTLESS TI/HA WAS NOT REPLACED.
Patient problems: Implant Pain
MAUDE report 25599056 ↗InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 8 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT IMPLANT SITE. A 36 MM CENTERED GLENOSPHERE, 36 MM + 6 STANDARD HUMERAL CUP, 2 STANDARD SCREWS, AND 2 LOCKING SCREWS WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 36 MM CENTERED GLENOSPHERE, 36 MM + 9 STABILITY HUMERAL CUP, AND 4 LOCKING SCREWS.
Patient problems: Medical device site infection
MAUDE report 24167400 ↗InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 11 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, WITH THE PATIENT REPORTING THAT THEY FELT AS IF THEY WERE DISLOCATING. THE REPRESENTATIVE NOTES THAT THE PATIENT HAS "SEVERE ANXIETY ISSUES". A 32 MM ECCENTRIC GLENOSPHERE AND A 32 MM + 3 STANDARD HUMERAL CUP WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 36 MM ECCENTRIC GLENOSPHERE AND A 36 MM + 3 135/145* STABILITY HUMERAL CUP.
Patient problems: Implant Pain
MAUDE report 23577494 ↗InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 7 DAYS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. A 40 MM CENTERED GLENOSPHERE AND A 40 MM + 9 135/145* HUMERAL STABILITY CUP WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH AN IDENTICAL GLENOSPHERE, IDENTICAL CUP, AND A 9 MM SPACER. FIRST NOTIFICATION OF REVISION OCCURRED ON (B)(6) 2025, HOWEVER, THE PER WAS CLOSED FOR NON-RESPONSE AFTER 3 ATTEMPTS WERE MADE FOR MORE INFORMATION. THE FIRST INFORMATION THAT GAVE INDICATION OF REPORTABILITY WAS RECEIVED BY FX ON 30-OCT-2025. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE.
Patient problems: Joint Dislocation
MAUDE report 23466215 ↗InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 4 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT THE IMPLANT SITE. A 32 MM CENTERED GLENOSPHERE AND A 32 MM + 6 HUMERAL STABILITY CUP WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH IDENTICAL COMPONENTS.
Patient problems: Medical device site infection
MAUDE report 23380667 ↗InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 8 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 CENTERED GLENOSPHERE AND A 36 MM + 6 STABILITY HUMERAL CUP WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 40 MM CENTERED GLENOSPHERE AND A 40 MM + 9 STABILITY HUMERAL CUP.
Patient problems: Joint Dislocation
MAUDE report 23314008 ↗InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 1 YEAR AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INSTABILITY OF UNKNOWN CAUSE. A 36 MM CENTERED GLENOSPHERE AND A 36 MM + 3 HUMERAL STANDARD CUP WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 40 MM CENTERED GLENOSPHERE AND A 40 MM + 6 HUMERAL STABILITY CUP.
Patient problems: Joint Laxity
MAUDE report 23100226 ↗InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 6 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT THE IMPLANT SITE. A 36 MM CENTERED GLENOSPHERE AND A 36 MM + 9 135/145 STABILITY HUMERAL CUP WERE EXPLANTED. THERE ITEMS WERE REPLACED BY A 36 MM CENTERED GLENOSPHERE, A 36 MM + 3 135/145 STABILITY HUMERAL CUP, AND A 9 MM SPACER.
Patient problems: Medical device site infection
MAUDE report 22963797 ↗InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 10 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 ECCENTRIC GLENOSPHERE AND A 36 MM + 9 STANDARD HUMERAL CUP WERE EXPLANTED. THESE PARTS WERE REPLACED WITH A 40 MM ECCENTRIC GLENOSPHERE, A 40 MM + 9 STANDARD HUMERAL CUP, AND 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 22298825 ↗InjuryJun 12, 2025Adverse 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) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT IMPLANT SITE. A 36 MM CENTERED GLENOSPHERE, A 36 MM + 3 STANDARD HUMERAL CUP, 2 LOCKING SCREWS, AND 2 STANDARD SCREWS. THESE PARTS WERE REPLACED WITH A 36 MM CENTERED GLENOSPHERE, 36 MM + 3 STANDARD HUMERAL CUP, 2 STANDARD SCREWS, AND 2 LOCKING SCREWS.
Patient problems: Medical device site infection
MAUDE report 22196340 ↗InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 1 YEAR AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT IMPLANT SITE. A 36 MM CENTERED GLENOSPHERE AND A 36 MM + 6 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 36 MM CENTERED GLENOSPHERE AND A 36 MM + 6 HUMERAL STABILITY CUP.
Patient problems: Medical device site infection
MAUDE report 22196339 ↗InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 5 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. 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH 40 MM CENTERED GLENOSPHERE AND A 40 MM + 6 135/145 HUMERAL STABILITY CUP.
Patient problems: Joint Dislocation
MAUDE report 21551898 ↗InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 10 WEEKS AFTER THE PRIOR REVISION SURGERY WHICH OCCURRED ON (B)(6) 2024. PRIMARY SURGERY OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. 32 MM CENTERED GLENOSPHERE AND 32 MM + 9 HUMERAL STABILITY CUP EXPLANTED. THESE WERE REPLACED WITH 36 MM CENTERED GLENOSPHERE AND A 36 MM + 3 HUMERAL STABILITY CUP.
Patient problems: Joint Dislocation
MAUDE report 20854399 ↗InjurySep 26, 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 INSTABILITY. 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 36 MM CENTERED GLENOSPHERE WITH SCREW AND A 36 MM + 9 STABILITY HUMERAL CUP.
Patient problems: Joint Laxity
MAUDE report 20315728 ↗InjurySep 6, 2024Adverse 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 (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO ACUTE INSTABILITY. 32 MM CENTERED GLENOSPHERE AND 32 MM + 6 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 40 MM ECCENTRIC GLENOSPHERE, 40 MM + 3 STABILITY HUMERAL CUP, AND 9 MM SPACER.
Patient problems: Joint Laxity
MAUDE report 20159866 ↗
Other Fx Solutions products
- Humelock II Cemented Reversible Shoulder23 models · 406 reports
- Humelock Cemented Shoulder Prosthesis7 models · 22 reports · 1 recall
- Humeral Cup Stability15 models · 65 reports
- 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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