MAUDE Adverse Event Report: CORIN LTD TRINITY; ACETABULAR HIP SYSTEM WITH HXLPE LINERS (COCR MODULAR HEAD)

Model Number	E321.236
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), how many dislocations that the patient experienced, patient weight, activity level and medical history, whether the patient followed correct post-op protocol, what the patient was doing at the time of the dislocations, what was implanted at the revision, whether the patient experienced any slips / falls or other trauma post primary surgery and 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 appropriate device details have been provided and the relevant device manufacturing 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 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.
Event or Problem Description
Trinity revision after approximatively 2 months due to dislocation.
Additional Manufacturer Narrative
(b)(4) final report.Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), how many dislocations that the patient experienced, patient weight, activity level and medical history, whether the patient followed correct post-op protocol, what the patient was doing at the time of the dislocations, what was implanted at the revision, whether the patient experienced any slips / falls or other trauma post primary surgery and an update on the patient post revision, was requested in order to progress with the investigation of this event.Not all information could be provided, however, the reporter confirmed that the patient had not followed post-op protocol.The appropriate device details were provided and the relevant device manufacturing record has been identified and reviewed.All parts associated with this record conformed to material and dimensional specification at the time of manufacture.Based on the information provided by the reporter it has been confirmed that the dislocation did not occur as a result of the device design or performance but due to the patient not adhering to post-op protocol.Therefore, 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 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.
Event or Problem Description
Trinity revision after approximatively 2 months due to dislocation.

• Brand Name: TRINITY
• Common Device Name: ACETABULAR HIP SYSTEM WITH HXLPE LINERS (COCR MODULAR HEAD)
• 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: 22126225
• Report Number: 9614209-2025-00512
• Device Sequence Number: 7292377
• Product Code: LZO
• UDI-Device Identifier: 05055196937154
• UDI-Public: 05055196937154
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110087
• 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): 08/14/2025

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
• Operator of Device: Health Professional
• Device Model Number: E321.236
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 574682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2025
• Supplement Date Received by Manufacturer: 05/24/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female