HUMERIS 400-1102

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-02 for HUMERIS 400-1102 manufactured by Fx Solutions.

Event Text Entries

[188257885] 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.
Patient Sequence No: 1, Text Type: N, H10


[188257886] Revision surgery occurred (b)(6) 2020 for an unknown reason. All product fx solutions were removed : humeral steam size 12, double taper, centered head, 3-4 pegs glenoid. Primary surgery occurred in 2019. As far as we know, it has been highlighted during the revision surgery that the glenoid was unsealed (unknown reason). All the component part of the prothesis were removed, the replacement products are not fx products.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3009532798-2020-00096
MDR Report Key9774076
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-02
Date of Report2020-02-21
Date of Event2020-01-27
Date Mfgr Received2020-02-13
Device Manufacturer Date2018-07-23
Date Added to Maude2020-03-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. CEDRIC JOLY
Manufacturer Street1663 RUE DE MAJORNAS
Manufacturer CityVIRIAT, 01440
Manufacturer CountryFR
Manufacturer Postal01440
Manufacturer G1FX SOLUTIONS
Manufacturer Street1663 RUE DE MAJORNAS
Manufacturer CityVIRIAT, 01440
Manufacturer CountryFR
Manufacturer Postal Code01440
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUMERIS
Generic NameSHOULDER PROTHESIS
Product CodeHSD
Date Received2020-03-02
Catalog Number400-1102
Lot NumberM0945
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerFX SOLUTIONS
Manufacturer Address1663 RUE DE MAJORNAS VIRIAT, 01440 FR 01440


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-02

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