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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK II REVERSED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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FX SOLUTIONS HUMELOCK II REVERSED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION Back to Search Results
Model Number 105-0024
Date of Event 02/14/2022
Type of Reportable Event Serious Injury
Event or Problem Description
The patient was revised on (b)(6) 2022 following the primary surgery on (b)(6) 2021 due to dislocation.The surgeon explanted a humeral cup (32/9), glenoid baseplate (24), centered glenosphere (32), 2 cortical screws (24), a standard screw (30), and 3 locking screws (15mm, 20 mm and 26mm), retaining the humelock ii stem and implanted an offset head (46x18) and a double taper (0).
 
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Brand Name
HUMELOCK II REVERSED
Common Device Name
SHOULDER PROSTHESIS, REVERSE CONFIGURATION
Manufacturer (Section D)
FX SOLUTIONS
1663 rue de majornas
viriat, 01440
FR  01440
MDR Report Key13762840
Report Number3014128390-2022-00007
Device Sequence Number12255661
Product Code PHX
UDI-Device Identifier03701037300237
UDI-Public03701037300237
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2022
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/14/2022
Report Date (Section F) 03/14/2022
1 Device 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 Date04/01/2026
Device Model Number105-0024
Device Catalogue Number105-0024
Device Lot NumberP2352
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date02/16/2022
Event Location Hospital
Date Report to Manufacturer02/16/2022
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/14/2022
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Date Report Sent to FDA03/14/2022
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