TRINITY DUAL MOBILITY 321.02.348 NOT APPLICABLE

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 2020-03-17 for TRINITY DUAL MOBILITY 321.02.348 NOT APPLICABLE manufactured by Corin Medical.

Event Text Entries

[187240410] Per (b)(4). The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed. It was found that all finished parts associated with these records were manufactured, packed and sterilised to the correct specifications at the time of manufacture. The sterilisation method and sterile barrier system used to package trinity dual mobility devices has a long history of safe and effective use at corin for a wide range of orthopaedic devices and has been validated in accordance with the relevant standards. Infection is a known complication with any invasive surgery and thus this case is now considered closed. Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
Patient Sequence No: 1, Text Type: N, H10


[187240411] Trinity dual mobility revision after approximately 2 months due to infection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614209-2020-00029
MDR Report Key9841938
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2020-02-25
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-01-15
Date Added to Maude2020-03-17
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 FRANCK DIDIER
Manufacturer StreetTHE CORINIUM CENTRE CIRENCESTER
Manufacturer CityGLOUCESTERSHIRE, GL7 1YJ
Manufacturer CountryUK
Manufacturer PostalGL7 1YJ
Manufacturer G1CORIN MEDICAL
Manufacturer StreetTHE CORINIUM CENTRE CIRENCESTER
Manufacturer CityGLOUCESTERSHIRE, GL7 1YJ
Manufacturer CountryUK
Manufacturer Postal CodeGL7 1YJ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRINITY DUAL MOBILITY
Generic NameACETABULAR HIP SYSTEM
Product CodeMEH
Date Received2020-03-17
Model Number321.02.348
Catalog NumberNOT APPLICABLE
Lot Number407184
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCORIN MEDICAL
Manufacturer AddressTHE CORINIUM CENTRE CIRENCESTER GLOUCESTERSHIRE, GL7 1YJ UK GL7 1YJ


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.