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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 DIAMETER 36+9
Health Effect - Clinical Codes Fall (1848); Joint Dislocation (2374)
Date of Event 06/03/2021
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 on (b)(6) 2021 due to dislocation from falling out of bed, approximately 6 weeks after primary surgery.Surgeon explanted 36/+9 standard humeral cup and replaced it with a 36/+6 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 Key12159241
Report Number3009532798-2021-00098
Device Sequence Number4170172
Product Code PHX
UDI-Device Identifier03701037300114
UDI-Public03701037300114
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K150488
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) 07/12/2021
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 Date03/01/2025
Device Model NumberDIAMETER 36+9
Device Catalogue Number103-0809
Device Lot NumberN1431
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/07/2021
Initial Report FDA Received Date07/13/2021
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;
Patient Age63 YR
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