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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 mm ECCENTRIC
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/23/2021
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 infection, approximately 1 year after primary surgery.Surgeon converted reverse to a hemi, explanting all components except for stem (36/+3 standard humeral cup, 36mm eccentric glenosphere with screw, 24mm glenoid baseplate, 2 standard screws, and 2 locking screws), and then implanting +0mm double taper and 39x14 centered humeral head.
 
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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 Key11594202
Report Number3009532798-2021-00037
Device Sequence Number17022129
Product Code PHX
UDI-Device Identifier03701037300275
UDI-Public03701037300275
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 Year2020
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) 03/31/2021
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 Date03/01/2023
Device Model NumberDIAMETER 36 mm ECCENTRIC
Device Catalogue Number105-3613
Device Lot NumberL2569
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/28/2021
Initial Report FDA Received Date03/31/2021
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 Age73 YR
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