Humelock Reversed System 105-3210Recalls & reported problems
Fx Solutions · HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø32mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03701037309476), received between Mar 15, 2024 and Jul 16, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Inaccurate Information” (1 report).
1 other recall cover devices cleared under the same FDA submission (K192206); 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
- Inaccurate Information1
- Lack of Effect1
- Migration1
Patient problems
- Implant Pain1
- Inadequate Osseointegration1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2024Lack of Effect; Lack of Effect
REVISION OCCURRED APPROXIMATELY 20 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2022. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO PAIN AT IMPLANT SITE. 32 MM CENTERED GLENOSPHERE AND 32 MM + 3 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 32 MM ECCENTRIC GLENOSPHERE AND 32 MM + 6 STANDARD HUMERAL CUP.
Patient problems: Implant Pain
MAUDE report 19752856 ↗InjuryMay 15, 2024Migration; Migration
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 LOOSENING OF THE GLENOSPHERE. CENTERED 32 MM GLENOSPHERE AND 32 MM + 3 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH 36 MM ECCENTRIC GLENOSPHERE AND 36 MM + 6 STABILITY HUMERAL CUP.
Patient problems: Inadequate Osseointegration
MAUDE report 19322320 ↗MalfunctionMar 15, 2024Inaccurate Information; Inaccurate Information
A 40 MM CENTERED GLENOSPHERE WAS PRESENT IN 32 MM CENTERED GLENOSPHERE PACKAGING. PACKAGING INFORMATION: REF 105-3210 LOT: U0248. ITEM WAS 105-4010, A ONE-OF-A-KIND TEST PART. NO SURGICAL DELAY, AS ANOTHER 32 MM GLENOSPHERE WAS AVAILABLE IN THE KIT. A SCAR WAS ISSUED TO MEDICAL GROUP UNDER SCAR 24-08. MEDICAL GROUP'S NUMBER IS REC 23-10-008. ASSOCIATED WITH NC 23-0656. MEDICAL GROUP'S INVESTIGATED WAS COMPLETED AND ACCEPTED BY FX ON 15-MAR-24.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18913731 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192206. One submission often covers many models, so check the product and lot details in each record.
- Z-1402-2025 · Feb 19, 2025 · Open, ClassifiedMerge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical devic
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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