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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 322.04.932
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 10/04/2019
Event Type  Injury  
Manufacturer Narrative
Per 2490 initial report.The appropriate device details have been provided and the relevant device manufacturing records shall be identified and reviewed, details of this review will be provided in a supplemental report upon completion of the investigation.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
A patient had a washout and trinity revision of the head and liner after approximately 1 month due to infection.
 
Manufacturer Narrative
Per (b)(4) final report: the appropriate device details were provided and the relevant device manufacturing records and sterilisation certificates have been identified and reviewed.All finished parts associated with these records were manufactured, packaged and sterilised in accordance with the correct specifications at the time of manufacture.The sterilisation method and sterile barrier system used to package trinity / taperfit devices has a long history of safe and effective use at corin and has been validated in accordance with the relevant standards.Infection is a known complication with any invasive surgery and thus this case is now considered closed.Please note: this report is filed with the fda due to an 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.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
 
Event Description
A patient had a washout and trinity revision of the head and liner after approximately 1 month due to infection.
 
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Brand Name
TRINITY
Type of Device
ACETABULAR HIP SYSTEM WITH ECIMA LINERS
Manufacturer (Section D)
CORIN MEDICAL
the corinium centre
cirencester
gloucestershire, GL7 1 YJ
UK  GL7 1YJ
MDR Report Key9244419
MDR Text Key168616953
Report Number9614209-2019-00108
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K111481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/04/2023
Device Model Number322.04.932
Device Catalogue NumberNOT APPLICABLE
Device Lot Number394242
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/04/2019
Initial Date FDA Received10/28/2019
Supplement Dates Manufacturer Received10/04/2019
Supplement Dates FDA Received01/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COCR MODULAR HEAD - E321.232, 383364; TAPERFIT CENTRALISER - 588.0001, 427201; TAPERFIT CENTRALISER - 588.0002, 427201; TAPERFIT CENTRALISER - 588.0002, 429322; TAPERFIT CENTRALISER - 588.0002, 429322; TAPERFIT STEM - 580.3801, 423651; TAPERFIT STEM - 580.3801, 423651; TRINITY COCR MOD HEAD - E321.232, 383364; TRINITY CUP - 321.04.354, 424813; TRINITY CUP - 321.04.354, 424813; TRINITY SCREW - 321.040, 427163; TRINITY SCREW - 321.040, 427163
Patient Outcome(s) Hospitalization; Required Intervention;
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