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Humelock Cemented Shoulder Prosthesis 106-3900Recalls & reported problems

Fx Solutions · Humelock Cemented Shoulder Prosthesis, OFFSET HEAD CrCo 39x15 · 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 03701037300466), received between Aug 5, 2021 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

  • Adverse Event Without Identified Device or Use Problem1
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Insufficient Information1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem

    THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO CUFF TEAR. APPROXIMATELY 3 YEARS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 ECCENTRIC HEAD, 1 DOUBLE TAPER AND 1 2 PEGS GLENOID. THE SURGEON IMPLANTED 1 GLENOID BASEPLATE, 1 POST-EXTENSION, 3 STANDARD SCREW, 1 HUMERAL CUP 135/145° Ø36+3, 1 LOCKING SCREW AND 1 CENTERED GLENOSPHERE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 13994503 ↗
  • InjuryAug 5, 2021Appropriate Device Problem Term/Code Not Available

    PATIENT REVISED ON (B)(6) 2021 DUE TO ROTATOR CUFF TEAR FROM FALL, FOLLOWING PRIMARY SURGERY ON (B)(6) 2020. SURGEON CONVERTED ANATOMIC TO A REVERSE, EXPLANTING ALL COMPONENTS EXCEPT STEM (3-4 PEG GLENOID SIZE S, 39X15 OFFSET COCR HEAD, +0MM DOUBLE TAPER), AND THEN IMPLANTING A 135/145 32/+3 STANDARD HUMERAL CUP, 32MM CENTERED GLENOSPHERE WITH SCREW, 24MM CEMENTLESS GLENOID BASEPLATE, AND 4 LOCKING SCREWS.

    Patient problems: Insufficient Information

    MAUDE report 12279185 ↗

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 · Terminated
    Fx 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
  • Z-2468-2018 · Jun 4, 2018 · Terminated
    Fx 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

Other Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented devices

All Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page