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

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.

• 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 Key: 9244419
• MDR Text Key: 168616953
• Report Number: 9614209-2019-00108
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K111481
• Number of Events Reported: 1
• 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 Date: 07/04/2023
• Device Model Number: 322.04.932
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 394242
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• 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