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U.S. Department of Health and Human Services

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

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CORIN MEDICAL TRINITY DUAL MOBILITY ACETABULAR HIP SYSTEM Back to Search Results
Model Number 325.05.045
Device Problem No Apparent Adverse Event (3189)
Patient Problem Bone Fracture(s) (1870)
Event Date 09/25/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4) combined report. The reporter has confirmed that there was no issue with the trinity dual mobility ecima insert and that it was removed as a necessity, along with a non-corin head and stem. The patient fell post primary surgery, resulting in a femoral perirosthetic fracture and the subsequent revision. The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed. All parts associated with these records conformed to material and dimensional specification at the time of manufature. 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 due to the patient experiencing a fall and subsequent periprosthetic femoral fracture post primary surgery. A non-corin stem and head were revised. The reporter has stated that there was no issue with the corin device and that it was only removed as a necessity.
 
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Brand NameTRINITY DUAL MOBILITY
Type of DeviceACETABULAR HIP SYSTEM
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 Key12588500
MDR Text Key275144469
Report Number9614209-2021-00117
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 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number325.05.045
Device Catalogue NumberNOT APPLICABLE
Device Lot Number445769
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/23/2019
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: 10/07/2021 Patient Sequence Number: 1
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