MAUDE Adverse Event Report: CORIN LTD TRINITY DUAL MOBILITY; TRINITY¿ DUAL MOBILITY SYSTEM

Model Number	321.02.532
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Metal Related Pathology (4530); High metal ion levels (4847)
Date of Event	09/02/2025
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), patient activity level and medical history, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery, whether there were any signs of implant impingement, can the devices be returned for examination, whether any photos taken of the explanted devices and an update on the patient post revision has been requested in order to progress with the investigation of this event, and if receieved, 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 dual mobility revision of the cocr liner, ecima insert and modular head after approximately 2 years and 11 months due to metallosis.
Event or Problem Description
Trinity dual mobility revision of the cocr liner, ecima insert and modular head after approximately 2 years and 11 months due to metallosis.
Additional Manufacturer Narrative
Per (b)(4) final report.Additional information including post primary and pre revision x-rays, operative notes (primary and revision), patient activity level and medical history, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery, whether there were any signs of implant impingement, can the devices be returned for examination, whether any photos taken of the explanted devices and an update on the patient post revision was requested in order to progress with the investigation of this event, however, this information was not provided and thus the scope of the investigation was limited.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these reports conformed to material and dimensional specification at the time of manufacture.Based on the available information, no further investigation can be conducted and the root cause of the reported metallosis could not be determined, 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.

• Brand Name: TRINITY DUAL MOBILITY
• Common Device Name: TRINITY¿ DUAL MOBILITY SYSTEM
• 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: 23106906
• Report Number: 9614209-2025-00582
• Device Sequence Number: 18662555
• Product Code: LZO
• UDI-Device Identifier: 05055343893210
• UDI-Public: 05055343893210
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/27/2025

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: 321.02.532
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 494074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2022
• 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 COCR MODULAR HEAD: E321.022, (B)(6).; TRINITY COCR MODULAR HEAD: E321.022, (B)(6).; TRINITY DM ECIMA INSERT: 325.02.034, (B)(6).; TRINITY DM ECIMA INSERT: 325.02.034, (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 100 KG