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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK; SHOULDER PROSTHESIS
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FX SOLUTIONS HUMELOCK; SHOULDER PROSTHESIS Back to Search Results
Model Number DIAMETER 46 mm OFFSET
Health Effect - Clinical Code Rupture (2208)
Date of Event 02/26/2021
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
Revision surgery due to a heavy rupture of the supraspinatus occured on (b)(6) 2021.Double taper, ø46 eccentric head, ø36 cage and associated screws were removed and replaced by ø24 baseplate, ø36 eccentric glenosphere, 135/145° standard humeral cup and associated screws.
 
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Brand Name
HUMELOCK
Common Device Name
SHOULDER PROSTHESIS
Manufacturer (Section D)
FX SOLUTIONS
1663 rue des majornas
viriat, 01440
FR  01440
MDR Report Key11641735
Report Number3009532798-2021-00040
Device Sequence Number3099434
Product Code HSD
UDI-Device Identifier03701037300497
UDI-Public03701037300497
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K111097
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/07/2021
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 Date04/01/2023
Device Model NumberDIAMETER 46 mm OFFSET
Device Catalogue Number106-4600
Device Lot NumberL1263W
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/04/2021
Initial Report FDA Received Date04/09/2021
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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