TiN Coated Glenosphere 115-3210Recalls & reported problems
Fx Solutions · HUMELOCK REVERSED CENTERED 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03701037309551), received between Sep 6, 2024 and Jun 23, 2026 — classified as 4 injuries.
1 FDA recall record name this device's 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, 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
Recalls naming this device
- Aug 8, 2023Class IIOpen, Classified
Centered glenosphere box may contain an eccentric glenosphere.
Z-0843-2024 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Implant Pain1
- Joint Dislocation1
- Joint Laxity1
- Medical device site infection1
Recent adverse event reports
The 4 most recent of 4 reports, 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 ↗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 ↗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 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 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 · each recall links to the FDA recall notice
- 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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