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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS FX SOLUTIONS; REVERSED SHOULDER PROSTHESIS
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FX SOLUTIONS FX SOLUTIONS; REVERSED SHOULDER PROSTHESIS Back to Search Results
Model Number DIAMETER 40 mm ECCENTRIC
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 07/28/2021
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 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.
 
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Brand Name
FX SOLUTIONS
Common Device Name
REVERSED SHOULDER PROSTHESIS
Manufacturer (Section D)
FX SOLUTIONS
1663 rue des majornas
viriat, 01440
FR  01440
MDR Report Key12405574
Report Number3009532798-2021-00130
Device Sequence Number19879232
Product Code PHX
UDI-Device Identifier03701037300312
UDI-Public03701037300312
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) 08/13/2021
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 Date07/01/2025
Device Model NumberDIAMETER 40 mm ECCENTRIC
Device Catalogue Number105-4011
Device Lot NumberN2180
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/02/2021
Initial Report FDA Received Date09/01/2021
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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