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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK II; SHOULDER PROSTHESIS
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FX SOLUTIONS HUMELOCK II; SHOULDER PROSTHESIS Back to Search Results
Model Number Size 12 Cementless
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 03/24/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The event took place outside of the united states (in (b)(6)) and was associated with a product that is also cleared for the market within the united states.
 
Event or Problem Description
The event was a revision surgery due to postop fracture (due to trauma) that occured approximately 2 months after the primary surgery.The primar surgery used the anatomical humelock ii system.During the revision surgery, the surgeon explanted all the components : the +0 double taper, the size 12 cementless stem, the 39x15 offset head, a cortical screw and smartloops.
 
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Brand Name
HUMELOCK II
Common Device Name
SHOULDER PROSTHESIS
Manufacturer (Section D)
FX SOLUTIONS
1663 rue des majornas
viriat, 01440
FR  01440
MDR Report Key11796989
Report Number3009532798-2021-00056
Device Sequence Number3661335
Product Code HSD
UDI-Device Identifier03701037301067
UDI-Public03701037301067
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K130759
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date12/01/2025
Device Model NumberSize 12 Cementless
Device Catalogue Number311-0212
Device Lot NumberP1534
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/29/2021
Initial Report FDA Received Date05/10/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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