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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 Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problem Bone Fracture(s) (1870)
Event Date 03/21/2022
Event Type  Injury  
Manufacturer Narrative
Per (b)(4) initial report. Additional information, including post primary and pre revision x-rays, operative notes, whether the patient followed correct post-op protocol, what the patient was doing at the time of the fracture, and an update on the patient post revision 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 explanted devices are not available to return for examination. The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed. 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.
 
Event Description
Trinity dual mobility revision of the ecima insert and trinity biolox delta ceramic head on the same day as primary surgery due to a femur fracture being discovered 4 hours post-op. A non-corin stem was 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 Key13977057
MDR Text Key288380638
Report Number9614209-2022-00021
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
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,Followup
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
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 Number495127
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/06/2022
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: 04/01/2022 Patient Sequence Number: 1
Treatment
BIOLOX DELTA CERAMIC HEAD: 104.2805, 498934; TRINITY CUP: 321.03.350, 486420; TRINITY DM COCR LINER: 321.03.536, 492487
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