MAUDE Adverse Event Report: CORIN LTD TRINITY DUAL MOBILITY; COCR LINER SIZE 4

Model Number	321.04.540
Medical Device Problem Codes	Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): fda initial report.Additional information including x-rays, operative notes, patient weight, activity level and medical history, if the patient experienced any slips/ falls or other trauma, if the patient followed correct post op protocol, 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 and sterilisation records will be identified and reviewed.Please note: 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 liner and omni ceramic modular head revision after approximatively 3 years due to instability.
Additional Manufacturer Narrative
Per (b)(4) - fda final report.Additional information including x-rays, operative notes, patient weight, activity level and medical history, if the patient experienced any slips/ falls or other trauma, if the patient followed correct post op protocol, and an update on the patient post revision, has been requested in order to progress with the investigation of this event.However, this information was not available.The appropriate devices details have been provided and the relevant device manufacturing records have been identified and reviewed.The devices were manufactured according to specifications at the time of manufacture.Based on the information indicated on the label h3-52804 lot 38583, the omni hip ceramic femoral head 28mm +3.5mm should be used only with the omni hip system.Consequently, the omni ceramic heads are not cleared with corin acetabular systems.Based on the above, no further investigation can be conducted.The root cause is considered as an off-label use.Corin now considers this case closed.Please note: the submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contribted to this event.
Event or Problem Description
Trinity liner and omni ceramic modular head revision after approximatively 3 years due to instability.

• Brand Name: TRINITY DUAL MOBILITY
• Common Device Name: COCR LINER SIZE 4
• 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, gloucerstershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 23207381
• Report Number: 9614209-2025-00590
• Device Sequence Number: 15967811
• Product Code: LZO
• UDI-Device Identifier: 05055343893234
• UDI-Public: 05055343893234
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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 Expiration Date: 09/02/2026
• Device Model Number: 321.04.540
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 485571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2021
• 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: OMNI / FEMORAL HEAD: H3-52804 LOT 38583; OMNI / FEMORAL HEAD: H3-52804 LOT 38583
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male