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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 322.03.936
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 10/04/2021
Event Type  Injury  
Manufacturer Narrative
Per -(b)(4) initial report. Additional information, including post primary and pre revision x-rays, operative notes, patient medical history 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 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 revision of the ecima liner and ceramic head after approximately 8 weeks due to infection.
 
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Brand NameTRINITY
Type of DeviceACETABULAR HIP SYSTEM WITH ECIMA LINERS
Manufacturer (Section D)
CORIN MEDICAL
the corinium center
cirencester, GL7 1 YJ
UK GL7 1YJ
Manufacturer (Section G)
CORIN MEDICAL
the corinium center
cirencester, GL7 1 YJ
UK GL7 1YJ
Manufacturer Contact
marie-anne euzen
the corinium center
cirencester, GL7 1-YJ
UK   GL7 1YJ
MDR Report Key12671069
MDR Text Key277604123
Report Number9614209-2021-00125
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeNZ
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 12/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number322.03.936
Device Catalogue NumberNOT APPLICABLE
Device Lot Number472223
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2021
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: 10/21/2021 Patient Sequence Number: 1
Treatment
BIOLOX DELTA CERAMIC HEAD: 104.3605, 455524
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