HUMELOCK REVERSED 105-0024

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-20 for HUMELOCK REVERSED 105-0024 manufactured by Fx Solutions.

Event Text Entries

[184272271] 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


[184272272] Revision surgery due to a dismantling occurred (b)(6) 2019. All the component parts of the prothesis were removed (? 36/12 humeral stem,? 36 glenosphere,? 36+6 humeral cup, glenoid baseplate and associated screws), no information available about the replacement products. Patient underwent two previous revision surgeries for the same problem ((b)(6) 2019 and (b)(6) 2019). During the second revision surgery the surgeon removed a bony margin near the glenoid baseplate but did not changed it. Primary surgery occurred (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3009532798-2020-19499
MDR Report Key9859832
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2019-10-01
Date Mfgr Received2019-10-04
Device Manufacturer Date2018-10-04
Date Added to Maude2020-03-20
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 NameHUMELOCK REVERSED
Generic NameREVERSED SHOULDER PROTHESIS
Product CodePHX
Date Received2020-03-20
Catalog Number105-0024
Lot NumberM2317
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
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 2020-03-20

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