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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM WITH ECIMA LINER

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CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM WITH ECIMA LINER Back to Search Results
Model Number 322.05.940
Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 09/01/2021
Event Type  Injury  
Manufacturer Narrative
Per (b)(4)- initial report. Additional information, including post primary and pre revision x-rays, operative notes, patient details, patient medical history, an update on the patient post revision and information regarding stem / femoral head has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation. The appropriate device details of the ecima liner have been provided and the relevant device manufacturing record will be identified and reviewed.
 
Event Description
Trinity revision of the ecima liner after approximatively 6 years and 9 months due to a periprosthetic fracture following a fall.
 
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Brand NameTRINITY
Type of DeviceACETABULAR HIP SYSTEM WITH ECIMA LINER
Manufacturer (Section D)
CORIN MEDICAL
the corinium centre
cirencester, gloucestershire GL7 1 YJ
UK GL7 1YJ
Manufacturer (Section G)
CORIN MEDICAL
the corinium centre
cirencester, gloucestershire GL7 1 YJ
UK GL7 1YJ
Manufacturer Contact
marie-anne euzen
the corinium centre
cirencester, gloucestershire GL7 1-YJ
UK   GL7 1YJ
MDR Report Key12427492
MDR Text Key270044514
Report Number9614209-2021-00107
Device Sequence Number1
Product Code OQI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number322.05.940
Device Catalogue NumberNOT APPLICABLE
Device Lot Number425968
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/06/2021 Patient Sequence Number: 1
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