Humeris ShoulderRecalls & reported problems across all models
Fx Solutions · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls
- 0
We found 9 models of Humeris Shoulder by Fx Solutions in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Feb 18, 2021 and Sep 9, 2026 — classified as 35 injuries.
The most frequently reported specific device problem is “Microbial Contamination of Device” (5 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 Humeris Shoulder problems
Device problems
- Adverse Event Without Identified Device or Use Problem11
- Appropriate Device Problem Term/Code Not Available9
- Microbial Contamination of Device5
- Device Dislodged or Dislocated4
- Unstable3
- Migration2
- Break1
- Fracture1
Patient problems
- Medical device site infection8
- Insufficient Information6
- Joint Laxity4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Joint Dislocation3
- Unspecified Infection3
- Inadequate Osseointegration2
- Subluxation2
Humeris Shoulder models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Humeris Shoulder 316-0010Shoulder Prosthesis, Reverse Configuration9 reports
- Humeris Shoulder 316-0012Shoulder Prosthesis, Reverse Configuration7 reports
- Humeris Shoulder 316-0014Shoulder Prosthesis, Reverse Configuration7 reports
- Humeris Shoulder 316-0008Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented3 reports
- Humeris Shoulder 400-1101Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 reports
- Humeris Shoulder 400-1102Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 reports
- Humeris Shoulder 400-1104Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 reports
- Humeris Shoulder 316-0016Shoulder Prosthesis, Reverse Configuration2 reports
- Humeris Shoulder 400-1103Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 report
Recent Humeris Shoulder adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
The patient was revised due to dislocation and cup disassembly on (b)(6) 2026. The implantation date was on (b)(6) 2026. A cup and astem were explanted. A cup, screws and a stm were implanted.
Patient problems: Joint Laxity
MAUDE report 50687053 ↗InjuryJun 23, 2026Migration
REVISION OCCURRED ON (B)(6) 2026 APPROXIMATELY 364 DAYS AFTER THE PRIMARY WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA WAS REPORTED. BASED ON COMPARING USAGE FORMS, ONLY 3-4 PEGS GLENOID PE CEMENTED SIZE M, CENTERED HEAD 46X15 AND DOUBLE TAPER TA6V +0MM 0° WAS EXPLANTED DUE TO LOOSENING AND REPLACED WITH CENTERED HEAD 46X15 AND DOUBLE TAPER TA6V +0MM 0°. EASYTECH ANCHOR BASE TA6V Ø38 MM CEMENTLESS TI/HA WAS NOT REPLACED.
Patient problems: Inadequate Osseointegration
MAUDE report 25601374 ↗InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED ON (B)(6) 2026 APPROXIMATELY 105 DAYS AFTER THE PRIMARY WHICH OCCURRED ON (B)(6) 2026. NO FALL OR OTHER TRAUMA WAS REPORTED. BASED ON COMPARING USAGE FORMS, ONLY 3-4 PEGS GLENOID PE CEMENTED SIZE L AND CENTERED HEAD COCR/TIN 48X18 WAS EXPLANTED DUE TO INSTABILITY AND REPLACED WITH HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASEPLATE W/ SCREW TI/HA Ø24MM, +3MM LATERALIZED, HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TIN 10° TILT Ø36MM, HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +3, CENTRAL SCREW TA6V Ø4.5MM L.14MM, LOCKING SCREW TA6V Ø4.5MM L.25MM, LOCKING SCREW TA6V Ø4.5MM L.20MM AND TWO LOCKING SCREW TA6V Ø4.5MM L.15MM.
Patient problems: Joint Laxity
MAUDE report 25491660 ↗InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO AN INFECTION AND INSTABILITY ON (B)(6) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS AND A STEM WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 23630134 ↗InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP AND A STEM WERE EXPLANTED. A CUP, A HUMERAL SPACER AND A STEM WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 22544177 ↗InjuryMay 12, 2025Adverse 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) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A MÉTAGLÈNE, A GLÉNOSPHÈRE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A MÉTAGLÈNE, A GLÉNOSPHÈRE, SCREWS AND A STEM WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 22002843 ↗InjuryJan 17, 2025Migration; Migration
REVISION OCCURRED ON (B)(6) 2024, APPROXIMATELY 6 YEARS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2018. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO CHRONIC LOOSENING OF THE GLENOID. 52X21 OFFSET HEAD, 3-4 PEGS GLENOID SIZE L, AND DOUBLE TAPER CONE EXPLANTED. THESE PARTS WERE REPLACED WITH A 54X21 OFFSET HEAD, DOUBLE TAPER CONE, AND COMPETITOR GLENOID COMPONENTS.
Patient problems: Inadequate Osseointegration
MAUDE report 21183837 ↗InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2024. A CUP, A GLÉNOSPHÈRE AND A STEM WERE EXPLANTED. A CUP, A GLÉNOSPHÈRE AND A STEM WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 20124913 ↗InjuryJul 1, 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) 2018. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM WERE EXPLANTED. A SPACER WAS IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 19644107 ↗InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO SURGICAL CORRECTION (PÉRIPROSTHETIC BONE FRACTURE) ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2024. A CUP AND A STEM WERE EXPLANTED. A CUP AND A STEM WERE IMPLANTED.
Patient problems: Bone Fracture(s)
MAUDE report 19162471 ↗InjuryJul 28, 2023Microbial Contamination of Device; Microbial Contamination of Device
THE PATIENT WILL BE REVISED DUE TO AN INFECTION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2022. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM MAY BE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM COULD BE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 17412705 ↗InjuryJul 19, 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 DOUBLE TAPER, A PEGS GLENOID, AN OFFSET HEAD AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, A POST EXTENSION AND SCREWS WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 17348839 ↗InjuryJul 6, 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, A GLENOSPHERE, A METAGLENE AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS AND A STEM WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 17265812 ↗InjuryJul 6, 2023Unstable; Unstable
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6)2023. THE IMPLANTATION DATE WAS ON (B)(6)2022. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS, A POST EXTENSION AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS, A POST EXTENSION AND A STEM WERE IMPLANTED.
Patient problems: Subluxation
MAUDE report 17265115 ↗InjuryJun 16, 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, A GLENOSPHERE, A METAGLENE,A STEM, SCREWS AND SMARTAPE WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, A STEM, SCREWS AND POST EXTENSION WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 17141844 ↗
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
- Humeral Cup Stability15 models · 65 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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