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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK REVERSED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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FX SOLUTIONS HUMELOCK REVERSED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION Back to Search Results
Model Number 103-0809
Date of Event 02/14/2022
Type of Reportable Event Serious Injury
Event or Problem Description
The patient was revised on (b)(6) 2022 for the third time due to chronic instability.Details on previous shoulder surgeries are as below: 2nd revision: (b)(6) 2021 (mdr 3014128390-2021-00045).1st revision: (b)(6) 2020 (mdr 3014128390-2020-00056).Primary surgery: (b)(6) 2019.The surgeon explanted a humeral cup (36/9) and implanted a humeral spacer (9) and a humeral cup (36/6).
 
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Brand Name
HUMELOCK REVERSED
Common Device Name
SHOULDER PROSTHESIS, REVERSE CONFIGURATION
Manufacturer (Section D)
FX SOLUTIONS
1663 rue de majornas
viriat, 01440
FR  01440
MDR Report Key13763160
Report Number3014128390-2022-00006
Device Sequence Number20319057
Product Code PHX
UDI-Device Identifier03701037300114
UDI-Public03701037300114
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 Date07/01/2023
Device Model Number103-0809
Device Catalogue Number103-0809
Device Lot NumberM2165
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date02/15/2022
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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