TRINITY 321.03.354 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 2020-03-27 for TRINITY 321.03.354 NOT APPLICABLE manufactured by Corin Medical.

Event Text Entries

[186608516] Per (b)(4). Additional information, including the cup lot code, part nos. And lot cods of any other revised devices, operative notes, post primary and pre revision x-rays, patient "detais" and patient medical history was requested in order to progress with the investigation of this event, however, this information has not been provided and thus an investigation cannot be conducted. The lot code of the reported cup was not provided and thus the relevant device manufacturing records could not be identified or reviewed. As this event was not due to the performance of the device, but was the result of the patient experiencing a fall, this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.
Patient Sequence No: 1, Text Type: N, H10


[186608517] Trinity revision after approximately 5 years and 5 months due to cup migration following a fall.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614209-2020-00030
MDR Report Key9887846
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-02-25
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-27
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
Generic NameACETABULAR HIP SYSTEM
Product CodeLZO
Date Received2020-03-27
Model Number321.03.354
Catalog NumberNOT APPLICABLE
Lot NumberNOT PROVIDED
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 2020-03-27

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