Humelock Cemented Shoulder Prosthesis 106-4617Recalls & reported problems
Fx Solutions · Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 46x17 · Class 2 · Implant
All models of Humelock Cemented Shoulder Prosthesis (7)
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 03701037300411), received between Feb 2, 2022 and Apr 4, 2022 — classified as 2 injuries.
2 other recalls cover devices cleared under the same FDA submission (K111097); 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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INFECTION. APPROXIMATELY 1 YEAR AND 9 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 2PEGS GLENOID, 1 DOUBLE TAPER, 1 ANCHOR BASE AND 1 CENTERED HEAD.
Patient problems: Unspecified Infection
MAUDE report 13993395 ↗InjuryFeb 2, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 FOR CUFF TEAR. APPROXIMATELY 1 YEARS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 STEM, 1 DOUBLE TAPER AND 1 CENTERED HEAD. THE SURGEON IMPLANTED 1 GLENOID BASEPLATE, 1 STEM Ø36/10 , 1 ECCENTRED GLENOSPHERE, 2 LOCKING SCREW, 2 STANDARD SCREW, 1 HUMERAL CUP Ø40+6 AND 1 CORTICAL SCREW.
Patient problems: Insufficient Information
MAUDE report 13421310 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K111097. One submission often covers many models, so check the product and lot details in each record.
- Z-2468-2018 · Jun 4, 2018 · TerminatedFx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and ot
- Z-2469-2018 · Jun 4, 2018 · TerminatedFx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and othe
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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