Humelock II Cemented Shoulder System 105-0002Recalls & reported problems
Fx Solutions · 2 PEGS GLENOID PE CEMENTED SIZE S · 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 03701037300176), received between Apr 4, 2022 and Jan 27, 2025 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Insufficient Information1
- Joint Laxity1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO A LOOSENING ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2014.
Patient problems: Joint Laxity
MAUDE report 21240827 ↗InjuryApr 4, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO BREAK. APPROXIMATELY 5 YEARS AND 7 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 2 PEGS GLENOID, 1 DOUBLE TAPER, 1 ANCHOR BASE AND 1 HEAD 43X16. THE SURGEON IMPLANTED 1 HUMERAL CUP 135/145° Ø36+3, 1 ECCENTRIC GLENOSPHERE, 2 STANDARD SCREW, 1 GLENOID BASEPLATE AND 1 LOCKING SCREW.
Patient problems: Insufficient Information
MAUDE report 13993971 ↗
Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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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