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

Model Number	325.04.042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) initial report.Additional information including post primary and pre revision x-rays and operative notes (primary and revision) have been requested and if received, will be provided in a supplemental report upon completion of the investigation.The reporter has stated that the patient had followed correct post-op protocol, had not experienced any slips / falls or other trauma post primary and was doing well following the 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 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 biolox delta ceramic head after approximately 1 month due to pain, inflammation and infection.
Event or Problem Description
Trinity dual mobility revision of the cocr liner, ecima insert and biolox delta ceramic head after approximately 1 month due to pain, inflammation and infection.
Additional Manufacturer Narrative
Per (b)(4) final report: additional information including post primary and pre revision x-rays and opeative notes (primary and revision) have been requested and if received, will be provided in a supplemental report upon completion of the investigation.The reporter has stated that the patient had followed correct post-op protocol, had not experienced any slips / falls or other trauma post primary and was doing well following the revision.The appropriate device details were provided and the relevant device manufacturing and sterilisation records have been identified and reviewed.Review of these records releaved no product non-conformity or deviation from process that would have caused or contributed to this event.Based on the above, no further investigation can be conducted.Infection is a known complication with any invasive surgery and the reported devices were manufactured, packed and sterilised in accordance with the relevant standards.Thus the root cause of the reported infection has not been linked to the devices and 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: 23862892
• Report Number: 9614209-2025-00638
• Device Sequence Number: 9299600
• Product Code: LZO
• UDI-Device Identifier: 05055343893531
• UDI-Public: 05055343893531
• 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: 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): 03/18/2026

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: 325.04.042
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 599199
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2025
• Supplement Date Received by Manufacturer: 12/21/2025
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2025
• 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: BIOLOX DELTA CERAMIC HEAD: 104.2810, 608132.; BIOLOX DELTA CERAMIC HEAD: 104.2810, 608132.; TRINITY DM COCR LINER: 321.04.540, 598375.; TRINITY DM COCR LINER: 321.04.540, 598375.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male