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

Model Number	322.04.636
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per-10865 initial report.The following additional information was requested from the reporter: post primary and pre revision x-rays.Operative notes (primary and revision).Patient activity level and medical history.Did the patient follow correct post-op protocol? an update on the patient post revision.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 occured outside the usa.The submission of this report does not constitute an admission that the device reporting entities representative or distributer caused or contributed to this event.
Event or Problem Description
Trinity revision of the ecima liner after approximately 3 weeks due to infection.
Additional Manufacturer Narrative
(b)(4) final report the following additional information was requested from the reporter, but no response was received: - post primary and pre revision x-rays - operative notes (primary and revision) - patient activity level and medical history - did the patient follow correct post-op protocol? - an update on the patient post revision the appropriate device detials have been provided, and the relevant device manufacturing and sterilisation records were identified and reviewed.Review of these records revealed no product non conformity or deviation from process that would've caused or contributed to this event.Based on the available information no further investigation can be conducted.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 occured outside the usa.The submission of this report does not constitute an admission that the device reporting entities representitive or distrubuter caused or contributed to this event.
Event or Problem Description
Trinity revision of the ecima liner after approximately 3 weeks due to infection.

• Brand Name: TRINITY
• Common Device Name: ACETABULAR 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: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 22274447
• Report Number: 9614209-2025-00520
• Device Sequence Number: 3797540
• Product Code: OQI
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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 Model Number: 322.04.636
• Device Catalogue Number: N/A
• Device Lot Number: 586734
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male