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U.S. Department of Health and Human Services

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

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CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM WITH ECIMA LINERS Back to Search Results
Model Number NOT PROVIDED
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 11/18/2020
Event Type  Injury  
Manufacturer Narrative
Per -(b)(4) initial report. Additional information, including post primary and pre revision x-rays, operative notes, patient details, and update on the patient post revision and return of the explanted devices 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. Upon receipt of the appropriate device details the relevant device manufacturing records will be identified and reviewed.
 
Event Description
Trifit ts / trinity revision of the stem, head and liner after approximately 5 months and 2 weeks due to reported pain.
 
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Brand NameTRINITY
Type of DeviceACETABULAR HIP SYSTEM WITH ECIMA LINERS
Manufacturer (Section D)
CORIN MEDICAL
the coriunium 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 Key11170520
MDR Text Key226817656
Report Number9614209-2021-00010
Device Sequence Number1
Product Code MEH
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 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNOT PROVIDED
Device Catalogue NumberNOT APPLICABLE
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/14/2021 Patient Sequence Number: 1
Treatment
BIOLOX DELTA CERAMIC HEAD - DEVICE DETAILS UNKNOWN; TRIFIT TS HIP STEM - DEVICE DETAILS UNKNOWN
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