MAUDE Adverse Event Report: CORIN LTD TRINITY PLUS; TRINITY PLUS ACETABULAR SHELL

Model Number	324.04.756
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per -(b)(4) initial report: it has been confirmed that the device was explanted and the surgeon switched to a competitor device to successfully complete the surgery.The surgeon was satisfied with the outcome of the procedure, however, the patient will be called for additional follow-up.Return of the device for analysis will be requested.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.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
During surgery, the trinity plus shell would not seat and sat approximately 3mm proud.The surgeon explanted the trinity plus shell and switched to a competitor device.Patient will be called for additional follow-up.
Event or Problem Description
Duruing surgery, the trinity plus shell would not seat and sat approximately 3mm proud.The surgeon explanted the trinity plus shell and switched to a competitor device.Patient will be called for additional follow-up.
Additional Manufacturer Narrative
(b)(4) final report.It has been confirmed that the device was explanted and the surgeon switched to a competitor device to successfully complete the surgery.The surgeon was satisifed with the outcome of the procedure, however, the patient will be called for additional follow-up.The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.The reported device was returned and examined.The device was measured and it was confirmed to be within specification.The investigation has concluded that the root cause is not linked to the device design or performance.This case is now considered closed.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 PLUS
• Common Device Name: TRINITY PLUS ACETABULAR SHELL
• 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: 21321214
• Report Number: 9614209-2025-00447
• Device Sequence Number: 8485350
• Product Code: LPH
• UDI-Device Identifier: 05055343898147
• UDI-Public: 05055343898147
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172551
• 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): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 324.04.756
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 529306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• 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
• Patient Sex: Unknown