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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 325.05.045
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4) initial report. There has been no reported malfunction of the corin devices associated with this report. A trinity dual mobility ecima insert was revised along with a non-corin stem and head due to subsidence of the stem. The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed. Details of this review will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Revision of a trinity dual mobility ecima insert after 2 weeks due to subsidence of a non-corin stem. A non-corin stem and head were also revised. There has been no fault with the corin device.
 
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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 Key13937828
MDR Text Key288099793
Report Number9614209-2022-00020
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,Followup
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2022
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 Number473175
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2021
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: 03/29/2022 Patient Sequence Number: 1
Treatment
TRINITY CUP: 321.05.360, 483670; TRINITY DM COCR LINER: 321.05.540, 473911; TRINITY SCREW: 321.025, 485323; TRINITY SCREW: 321.025, 486405
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