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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK REVERSED; REVERSED SHOULDER PROSTHESIS
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FX SOLUTIONS HUMELOCK REVERSED; REVERSED SHOULDER PROSTHESIS Back to Search Results
Model Number 104-1006
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 07/12/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This mdr has already been submitted to fda by the us importer with report number (b)(4).
 
Event or Problem Description
Patient revised for second time on (b)(6) 2021.Primary surgery on (b)(6) 2021, and first revision on (b)(6) 2021 (previously reported).Surgeon explanted the 40/+6 stability humeral cup and implanted a larger 40/+9 stability humeral cup.
 
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Brand Name
HUMELOCK REVERSED
Common Device Name
REVERSED SHOULDER PROSTHESIS
Manufacturer (Section D)
FX SOLUTIONS
1663 rue des majornas
viriat, 01440
FR  01440
MDR Report Key12382654
Report Number3009532798-2021-00120
Device Sequence Number13751665
Product Code PHX
UDI-Device Identifier03701037309452
UDI-Public03701037309452
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K193394
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 distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/11/2021
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 Date09/01/2025
Device Model Number104-1006
Device Catalogue Number104-1006
Device Lot NumberN2312
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/15/2021
Initial Report FDA Received Date08/30/2021
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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