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

Model Number 322.03.636

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

Patient Problem Unspecified Infection (1930)

Event Date 03/11/2023

Event Type  Injury  

Event Description

Trinity revision of the ecima liner and cocr modular head after 5 weeks and 4 days due to infection.

Manufacturer Narrative

(b)(4) initial report.Additional information including post primary and pre revision x-rays, operative notes (primary and revision) 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 and sterilisation 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.

Manufacturer Narrative

Case- (b)(6) final report.Additional information including post primary and pre revision x-rays, operative notes (primary and revision) and an update on the patient post revision was requested in order to progress with the investigation of this event, however, this information was not provided and thus the scope of the investigation was limited.The appropriate device details were provided and the relevant device manufacturing and sterilisation records have been identified and reviewed.Review of these records revealed no deviation from process or product non-conformity that would have caused or contributed to the event.Based on the available information, the root cause of the infection could not be determined, however, 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.

• Brand Name: TRINITY
• Type of Device: 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: 17983664
• MDR Text Key: 326234489
• Report Number: 9614209-2023-00258
• 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: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 322.03.636
• Device Lot Number: 514944
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/11/2023
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2022
• 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: METAFIX COLLARED STEM: 579.2104, (B)(6).; TRINITY COCR MODULAR HEAD: E321.136, (B)(6).; TRINITY CUP: 321.03.352, (B)(6).
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female