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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK REVERSED SHOULDER; REVERSE CONFIGURATION SHOULDER PROSTHESIS
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FX SOLUTIONS HUMELOCK REVERSED SHOULDER; REVERSE CONFIGURATION SHOULDER PROSTHESIS Back to Search Results
Model Number DIAMETER 40+3
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/04/2021
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 unites states.
 
Event or Problem Description
The event was a revision for infection.The surgeon has explanted the 40+3 humeral cup and the ¿40 centered glenosphere and has implanted a new ¿40 centered glenosphere and a 40+9 humeral cup.
 
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Brand Name
HUMELOCK REVERSED SHOULDER
Common Device Name
REVERSE CONFIGURATION SHOULDER PROSTHESIS
Manufacturer (Section D)
FX SOLUTIONS
1663 rue des majornas
viriat, 01440
FR  01440
MDR Report Key11493974
Report Number3009532798-2021-00030
Device Sequence Number17136698
Product Code PHX
UDI-Device Identifier03701037300121
UDI-Public03701037300121
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K150488
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
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/08/2021
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 Date04/01/2024
Device Model NumberDIAMETER 40+3
Device Catalogue Number105-4010
Device Lot NumberN0039
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/16/2021
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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