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

Model Number 322.05.636

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/05/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report , additional information including; operative notes, x-rays (pre and post revision), an update on the patient following the revision and did the patient follow the correct post-op protocol has been requested 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.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

Trinity/metafix revision of cup, ecima liner, collared stem and biolox delta ceramic head after approximately 11 months due to infection.

Manufacturer Narrative

(b)(4) final report - additional information including; operative notes, x-rays (pre and post revision), an update on the patient following the revision and did the patient follow the correct post-op protocol were requested to the reporter on 16 sept, 23 nov and 30 nov but were not provided.The appropriate device details were provided and it was found all finished devices associated with this record was manufactured & sterilised to specification at the time of manufacture.The cleaning method, the sterilization method and sterile barrier system used to package trinity 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 procedure and the incident rate is followed by performing trending on reported events.Based on the available information, no further investigation can be conducted, and the root cause of the reported infection is unknown.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.

• Brand Name: TRINITY
• Type of Device: TRINITY ACETABULAR HIP SYSTEM WITH ECIMA LINERS
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 17866921
• MDR Text Key: 324865308
• Report Number: 9614209-2023-00250
• Device Sequence Number: 1
• Product Code: OQI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 322.05.636
• Device Lot Number: 505123
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/05/2023
• Date Manufacturer Received: 09/05/2023
• Date Device Manufactured: 08/04/2022
• 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: BILOX DELTA CERAMIC HEAD 104.3605, 510639; METAFIX COLLARED STEM 579.2107, 479427; TRINITY CUP 321.05.360, 502352
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male