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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 HUMERAL SPACER TA6V +9 mm
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 07/27/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This mdr has already been submitted to fda by the us importer with report number 3014128390-2021-00042.
 
Event or Problem Description
Patient revised on (b)(6) 2021 due to humeral spacer disassociating from humeral stem.Components implanted on (b)(6) 2021.Surgeon explanted 36/+9 stability humeral cup and +9mm humeral spacer, and then implanted a new 36/+9 stability humeral cup and new +9mm humeral spacer.
 
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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 Key12405798
Report Number3009532798-2021-00129
Device Sequence Number4181968
Product Code PHX
UDI-Device Identifier03701037300084
UDI-Public03701037300084
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K162455
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) 08/18/2021
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 Date05/01/2025
Device Model NumberHUMERAL SPACER TA6V +9 mm
Device Catalogue Number103-0007
Device Lot NumberP0258
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/29/2021
Initial Report FDA Received Date09/01/2021
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 Age66 YR
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