MAUDE Adverse Event Report: CORIN LTD (UK & FR) TRINITY; ACETABULAR HIP SYSTEM WITH ECIMA LINERS

Model Number	321.04.356
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity and metafix revision - infection.
Additional Manufacturer Narrative
Combined report, additional information including x-rays, op notes, patient information and an update on the patient post revision was requested in order to progress with the investigation of this event, however, not all information could be 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.It was found that all finished parts associated with these records were manufactured, packed and sterilised to the correct specifications at the time of manufacture.Based on the available information, no further investigation can be conducted and the root cause of the reported infection could not be determined, however, infection is a known complication with any invasive surgery.This case is now considered closed, however, should any additional information be provided then this case may be re-opened for further 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.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
• Common Device Name: ACETABULAR HIP SYSTEM WITH ECIMA LINERS
• Manufacturer (Section D): CORIN LTD (UK & FR); the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD (UK & FR); the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: jamie demedeiros ; the corinium centre; cirencester; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 15931374
• Report Number: 9614209-2022-00132
• Device Sequence Number: 20473836
• Product Code: MEH
• UDI-Device Identifier: 05055343869574
• UDI-Public: 05055343869574
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 321.04.356
• Device Catalogue Number: 322.04.636
• Device Lot Number: 499240
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CERAMIC HEAD: 104.3605, 502850; METAFIX COLLARED STEM: 579.0105, 489704; TRINITY CUP: 321.04.356, 499240
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male