Humelock II Cemented Shoulder System 106-4100Recalls & reported problems
Fx Solutions · OFFSET HEAD CrCo 41x16 · Class 2 · Implant
All models of Humelock II Cemented Shoulder System (9)
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 03701037300473), received between Feb 23, 2021 and May 11, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (1 report).
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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 11, 2021Therapeutic or Diagnostic Output Failure
PATIENT REVISED ON (B)(6) 2021 DUE TO SUBSCAPULARIS FAILURE APPROXIMATELY 4 MONTHS AFTER PRIMARY SURGERY. SURGEON CONVERTED ANATOMIC TO REVERSE, EXPLANTING THE 3-4 PEG GLENOID SIZE XS, 41X16 OFFSET HEAD, AND +0MM DOUBLE TAPER; AND THEN IMPLANTING COMPONENTS NECESSARY FOR A REVERSE CONFIGURATION (24MM BASEPLATE, +6MM POST EXTENSION, 36MM ECCENTRIC GLENOSPHERE WITH SCREW, 135/145 36/+3 STANDARD HUMERAL CUP, AND 4 LOCKING SCREWS).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11804457 ↗InjuryFeb 23, 2021Appropriate Device Problem Term/Code Not Available
PATIENT REVISED ON (B)(6) 2021 DUE TO CONTINUED PAIN FOLLOWING THE PRIMARY SURGERY ON (B)(6) 2020. SURGEON CONVERTED THE TOTAL ANATOMIC TO A REVERSE ; EXPLANTING THE SIZE S 3-4 PEG GLENOID, 41X16 OFFSET COCR HEAD, AND +0MM DOUBLE TAPER AND THEN IMPLANTING 135/145 36/+3 STANDARD HUMERAL CUP, 24MM GLENOID BASEPLATE, 36MM CENTERED GLENOSPHERE WITH SCREW, +6MM POST EXTENSION, 1 LOCKING SCREW, AND 4 STANDARD SCREWS.
Patient problems: Pain
MAUDE report 11363980 ↗
Other Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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