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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORIN MEDICAL TRINITY DUAL MOBILITY ACETABULAR HIP SYSTEM WITH ECIMA LINERS

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CORIN MEDICAL TRINITY DUAL MOBILITY ACETABULAR HIP SYSTEM WITH ECIMA LINERS Back to Search Results
Model Number 325.03.040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 03/27/2022
Event Type  Injury  
Manufacturer Narrative
Per (b)(4) combined report. The reporter stated that the patient fell post primary and fractured their femur so the stem (non-corin device) had to be revised. As part of this revision a non-corin head and the corin trinity dual mobility ecima insert were also revised. There has been no reported fault with the corin device. 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 this record conformed to material and dimensional specification at the time of manufacture. As the revision was caused by the patient experiencing a fall post primary and fracturing their femur, no further investigation is required and thus this case is now considered closed.
 
Event Description
Revision of a trinity dual mobility ecima insert after 10 days due to a femoral fracture from a fall. A non-corin head and stem were also revised.
 
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Brand NameTRINITY DUAL MOBILITY
Type of DeviceACETABULAR HIP SYSTEM WITH ECIMA LINERS
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 Key14052129
MDR Text Key288860664
Report Number9614209-2022-00023
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170359
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number325.03.040
Device Catalogue NumberNOT APPLICABLE
Device Lot Number476363
Was Device Available for Evaluation? No
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2021
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: 04/08/2022 Patient Sequence Number: 1
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