TiN Coated Glenosphere 115-4010Recalls & reported problems
Fx Solutions · HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10° TILT Ø40mm · Class 2 · Implant
All models of TiN Coated Glenosphere (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03701037300848), received between Mar 19, 2024 and Nov 4, 2025 — classified as 2 injuries.
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 Problem2
Patient problems
- Joint Dislocation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED ON (B)(6) 2024, APPROXIMATELY 4 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. 40 MM CENTERED GLENOSPHERE, 40 MM + 9 STANDARD HUMERAL CUP, AND 9 MM SPACER EXPLANTED. THESE PARTS WERE REPLACED WITH A 40 MM CENTERED GLENOSPHERE, 40 MM + 6 STABILITY HUMERAL CUP, AND TWO 9 MM SPACERS.
Patient problems: Joint Dislocation
MAUDE report 18936363 ↗
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 Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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