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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 CEMENTED Ø32/06
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 01/13/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The event took place outside of the usa (in (b)(6)) and was associated with a product that is also cleared for the market within the usa.
 
Event or Problem Description
Revision : loosening stem.Surgeon removed cemented stem and replaced by an other cemented stem.
 
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Brand Name
HUMELOCK REVERSED
Common Device Name
REVERSED SHOULDER PROSTHESIS
Manufacturer (Section D)
FX SOLUTIONS
1663 rue des marjonas
viriat, 01440
FR  01440
MDR Report Key11347876
Report Number3009532798-2021-00015
Device Sequence Number19844827
Product Code PHX
UDI-Device Identifier03701037301388
UDI-Public03701037301388
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K162455
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/16/2021
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 Date01/01/2023
Device Model NumberCEMENTED Ø32/06
Device Catalogue Number313-3206
Device Lot NumberL0952
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/19/2021
Initial Report FDA Received Date02/19/2021
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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