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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK II REVERSED; REVERSE SHOULDER PROSTHESIS
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FX SOLUTIONS HUMELOCK II REVERSED; REVERSE SHOULDER PROSTHESIS Back to Search Results
Model Number DIAMETER 36+6
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 03/03/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
The event was a revision surgery due to loosening that occured approximately 4 years after the primary surgery.The primary surgery used the humelock ii reversed system.During the revision surgery, the surgeon explanted the ø36/+6 humeral cup.He implanted medical devices from a competing company.
 
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Brand Name
HUMELOCK II REVERSED
Common Device Name
REVERSE SHOULDER PROSTHESIS
Manufacturer (Section D)
FX SOLUTIONS
1663 rue des majornas
viriat, 01440
FR  01440
MDR Report Key11892143
Report Number3009532798-2021-00049
Device Sequence Number3686010
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 Year2017
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/06/2021
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 No Information
Device Expiration Date11/01/2021
Device Model NumberDIAMETER 36+6
Device Catalogue Number313-0706
Device Lot NumberK331
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/16/2021
Initial Report FDA Received Date05/27/2021
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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