Humelock Cemented Shoulder Prosthesis 106-5019Recalls & reported problems
Fx Solutions · Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 50x19 · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03701037300435), received between Oct 8, 2021 and Oct 8, 2021 — classified as 1 injury.
1 FDA recall record name this device's identifier.
1 other recall 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.
Recalls naming this device
- Jun 4, 2018Class IITerminated
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
Z-2468-2018 · Root cause: Package design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 8, 2021Appropriate Device Problem Term/Code Not Available
THE EVENT WAS A REVISION SURGERY DUE TO ROTATOR CUFF TEAR. THE PRIMARY SURGERY USED THE EASYTECH ANATOMIC SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE +0MM DOUBLE TAPER AND THE 50X19 CENTERED HEAD. THEN, HE IMPLANTED A Ø36/+6 135/145 HUMERAL CUP, A 6MM POST EXTENSION, A Ø24 BASEPLATE, A Ø36 ECCENTRIC GLENOSPHERE AND ASSOCIATED SCREWS.
Patient problems: Unspecified Tissue Injury
MAUDE report 12598069 ↗
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-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 · 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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