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

Model Number 322.03.632

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

Per -2500 combined report.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All 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 and metafix devices has a long history of safe and effective use at corin for a wide range of orthopaedic devices 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 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.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

Patient had a washout after 1 month due to infection.No devices were revised during this procedure.

• 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
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester; gloucestershire, GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: franck didier ; the corinium centre; cirencester; gloucestershire, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 9290786
• MDR Text Key: 165465357
• Report Number: 9614209-2019-00114
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2019

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: 02/06/2023
• Device Model Number: 322.03.632
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 383163
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: METAFIX COLLARED STEM - 579.0104, 415210; TRINITY COCR HEAD - E321.032, 404421; TRINITY CUP - 321.03.350, 421125
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR