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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS REVERSED; REVERSED SHOULDER SYSTEM
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FX SOLUTIONS HUMERIS REVERSED; REVERSED SHOULDER SYSTEM Back to Search Results
Model Number HUMERIS STEM TA6V SIZE 10 CEMENTLESS Ti/HA
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 07/23/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The event took place outside of the united states (in france) and was associated with a product that is also cleared for the market within the united states.
 
Event or Problem Description
The event is a revision surgery due to dislocation that occured approximately 2 weeks after the primary surgery.The primary surgery used the humeris reversed system.During the revision surgery, the surgeon explanted the size 10 cementless stem, the 36/+9 135/145 humeral cup and the 36 centered glenosphere.Then he implanted a size 12 cementless stem, a 40/+9 135/145 humeral cup and a 40 eccentric glenosphere.
 
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Brand Name
HUMERIS REVERSED
Common Device Name
REVERSED SHOULDER SYSTEM
Manufacturer (Section D)
FX SOLUTIONS
1663 rue des majornas
viriat, 01440
FR  01440
MDR Report Key12405594
Report Number3009532798-2021-00126
Device Sequence Number19879233
Product Code PHX
UDI-Device Identifier03701037301555
UDI-Public03701037301555
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K163669
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 Date02/01/2026
Device Model NumberHUMERIS STEM TA6V SIZE 10 CEMENTLESS Ti/HA
Device Catalogue Number316-0010
Device Lot NumberP1134
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/29/2021
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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