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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS EASYTECH; SHOULDER PROSTHESIS
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FX SOLUTIONS EASYTECH; SHOULDER PROSTHESIS Back to Search Results
Model Number 314-0034
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/30/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The event took place outside of the united states (in (b)(6)).The anchor base and head were used with a glenoid not available in the us.
 
Event or Problem Description
This event was a revision surgery for total shoulder arthroplasty removal that occured approximately 6 years after the primary surgery.The primary surgery used the easytech anatomic system.During the revision surgery, the surgeon explanted all the components and implanted a new prosthesis from another manufacturer.He explanted the ø34 anchor base, the ø20 resurfacing glenoid, the +0 double taper and the 43x16 centered head.
 
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Brand Name
EASYTECH
Common Device Name
SHOULDER PROSTHESIS
Manufacturer (Section D)
FX SOLUTIONS
1663 rue des majornas
viriat, 01440
FR  01440
MDR Report Key12279174
Report Number3009532798-2021-00112
Device Sequence Number4599983
Product Code HSD
UDI-Device Identifier03701037301470
UDI-Public03701037301470
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K201391
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
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) 08/04/2021
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 Date08/01/2019
Device Model Number314-0034
Device Catalogue Number314-0034
Device Lot NumberI434
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/06/2021
Initial Report FDA Received Date08/05/2021
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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