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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
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 06/07/2021
Event Type  Injury  
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 Description
The event was a revision surgery due to cuff tear.Additional details (including date of primary surgery and explant information) are unknown.The surgeon converted the anatomic to a reverse configuration.He implanted a ø24 baseplate, a ø36 centered glenosphere, ø36/+3 stability humeral cup.
 
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Brand Name
EASYTECH
Type of Device
SHOULDER PROSTHESIS
Manufacturer (Section D)
FX SOLUTIONS
1663 rue des majornas
viriat, 01440
FR  01440
Manufacturer (Section G)
FX SOLUTIONS
1663 rue des majornas
viriat, 01440
FR   01440
Manufacturer Contact
ludovic badey
1663 rue des majornas
viriat, 01440
FR   01440
MDR Report Key12257967
MDR Text Key264472149
Report Number3009532798-2021-00104
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/23/2021
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
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/11/2021
Initial Date FDA Received08/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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