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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK II REVERSE; REVERSE SHOULDER PROSTHESIS
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FX SOLUTIONS HUMELOCK II REVERSE; REVERSE SHOULDER PROSTHESIS Back to Search Results
Model Number DIAMETER 36+6
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 01/19/2021
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 for dislocation.During the first pose, problem with the anaesthetist, shoulder too relaxed.The surgeon replaced the 36+6 humeral cup with a 36+9 cup.
 
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Brand Name
HUMELOCK II REVERSE
Common Device Name
REVERSE SHOULDER PROSTHESIS
Manufacturer (Section D)
FX SOLUTIONS
1663 rue de majornas
viriat, 01440
FR  01440
MDR Report Key11363970
Report Number3009532798-2021-00021
Device Sequence Number14264762
Product Code PHX
UDI-Device Identifier03701037301364
UDI-Public03701037301364
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K150488
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 02/22/2021
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 Date07/01/2025
Device Model NumberDIAMETER 36+6
Device Catalogue Number313-0706
Device Lot NumberM3130
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/28/2021
Initial Report FDA Received Date02/23/2021
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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