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

Model Number	322.03.636
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision of the ecima liner and biolox delta ceramic head due to liner disassociating from the shell.
Additional Manufacturer Narrative
Per (b)(4) initial report.The following additional information was requested from the reporter: date of the initial surgery? post primary and pre revision x-rays? operative notes (primary and revision).Patient weight, activity level and medical history? what was the patient doing at the time of the disassociation? 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 and biolox delta ceramic head due to liner dissasociating from the shell.
Additional Manufacturer Narrative
(b)(4) final report the following additional information was requested from the reporter: date of the initial surgery post primary and pre revision x-rays operative notes (primary and revision) patient weight, activity level and medical history what was the patient doing at the time of the disassociation did the patient follow correct post-op protocol? an update on the patient post revision.However, none of this additional information was provided.The appropriate device details have been provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.The investigation determined no device related reason for this failure.The dhr confirmed the polyethylene liner to be in specification, and the ceramic modular head was purchased to specification from ceramtec.It is suggested that the root cause may be related to incorrect shell positioning and/or incorrect liner seating, leading to impingement of the liner, leading to the liner dissociating.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 respresentivitive or distributer caused or contributed to this event.

• 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: 22565603
• Report Number: 9614209-2025-00538
• Device Sequence Number: 9229180
• Product Code: OQI
• UDI-Device Identifier: 05055343869550
• UDI-Public: 05055343869550
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/06/2026

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: 322.03.636
• Device Catalogue Number: N/A
• Device Lot Number: 568010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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: TRINITY BIOLOX DELTA CERAMIC HEAD:104.3610, 559398; TRINITY BIOLOX DELTA CERAMIC HEAD:104.3610, 559398
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female