TiN Coated Glenosphere 115-3613Recalls & reported problems
Fx Solutions · HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10° TILT Ø36mm · Class 2 · Implant
All models of TiN Coated Glenosphere (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03701037300817), received between Oct 20, 2023 and Jun 20, 2025 — classified as 3 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 Problem3
Patient problems
- Joint Dislocation2
- Joint Laxity1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 8 WEEKS AFTER THE PRIOR REVISION WHICH OCCURRED ON (B)(6) 2024. THE PRIOR REVISION OCCURRED FOR NON-COMPLIANCE. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. THIS REVISION OCCURRED FOR A DISLOCATION OF UNKNOWN CAUSE. 36 MM CENTERED GLENOSPHERE, 36 MM + 9 STABILITY HUMERAL CUP, AND 3 LOCKING SCREWS EXPLANTED. THESE PARTS WERE EXPLANTED AND REPLACED WITH A 40 MM ECCENTRIC GLENOSPHERE, 40 MM + 6 STABILITY HUMERAL CUP, 9 MM SPACER, AND 3 LOCKING SCREWS.
Patient problems: Joint Dislocation
MAUDE report 19524129 ↗InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DISLOCATION OF GLENOSPHERE AFTER APPROXIMATELY 5 MONTHS DUE TO JOINT INSTABILITY. PAIN REPORTED. 36 MM ECCENTRIC GLENOSPHERE AND 36 MM + 3 STANDARD HUMERAL CUP EXPLANTED. REPLACED WITH 36 MM ECCENTRIC GLENOSPHERE AND 36 MM + 3 STANDARD HUMERAL CUP EXPLANTED.
Patient problems: Joint Laxity
MAUDE report 17975249 ↗
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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