TiN Coated Glenosphere 115-3211Recalls & reported problems
Fx Solutions · HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10° TILT Ø32mm · Class 2 · Implant
All models of TiN Coated Glenosphere (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03701037309568), received between Nov 17, 2025 and Nov 17, 2025 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K191146); they may or may not involve this specific model.
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 Problem1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K191146. One submission often covers many models, so check the product and lot details in each record.
- Z-0843-2024 · Aug 8, 2023 · Open, ClassifiedCentered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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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