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

Model Number	322.04.640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) initial fda report.The following information was requested from the reporter: pre-revision and post primary x-rays, operative notes (primary and revision), patient activity level, weight and medical history.Did the patient follow the correct post-op protocol? an update on the patient post revision.However, the reporter confirmed that no additional information could be provided.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 5 months 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: 25299119
• Report Number: 9614209-2026-00063
• Device Sequence Number: 9248982
• Product Code: OQI
• UDI-Device Identifier: 05055343869581
• UDI-Public: 05055343869581
• 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: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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
• Operator of Device: Health Professional
• Device Model Number: 322.04.640
• Device Catalogue Number: N/A
• Device Lot Number: 604892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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: Unknown