MAUDE Adverse Event Report: CORIN LTD TRINITY; ACETABULAR HIP 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	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity/ metafix revision of ecima liner, biolox delta ceramic head and stem after 2.5 weeks due to infection and dislocation.
Additional Manufacturer Narrative
Per comp (b)(4) initial report - additional information including: - post primary and pre revision x-rays.- operative notes (primary and revision).- patient weight, activity level and medical history.- 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 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 experience with a device that is similar to those placed on the market in the usa, however, this event occured 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 or Problem Description
Trinity/ metafix revision of ecima liner, biolox delta ceramic head and stem after 2.5 weeks due to infection and dislocation.
Additional Manufacturer Narrative
Per (b)(4) final report: additional information including: post primary and pre revision x-rays, operative notes (primary and revision), patient weight, activity level and medical history, an update on the patient post revision.Has been requested in order to progress with the investigation of this event, however no additional information has been provided.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 product non-conformity or deviation from process that would have caused or contributed to the reported infection and dislocation.Based on the above, no further investigation can be conducted.Infection is a known risk with any invasive surgery and it has been stated by the surgeon that they believe the dislocation was due to swelling from the infection.Therefore, this case is now considered closed.The root cause of the infection could not be determined however, it has not been directly linked to the device design or performance.Please note: this report is filed with the fda due to an adverse event experience with a device that is similar to those placed on the market in the usa, however, this event occured 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; 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: 24178507
• Report Number: 9614209-2026-00007
• Device Sequence Number: 9524188
• 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: 2026
• 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): 03/18/2026

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: 322.04.636
• Device Catalogue Number: N/A
• Device Lot Number: 589400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/01/2026
• Supplement Date Received by Manufacturer: 01/01/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: METAFIX STEM: 579.2004, 563406; METAFIX STEM: 579.2004, 563406; TRINITY BIOLOX DELTA CERAMIC HEAD:104.3615, 547772; TRINITY BIOLOX DELTA CERAMIC HEAD:104.3615, 547772
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male