MAUDE Adverse Event Report: CORIN LTD TRINITY; TRINITY MULTI HOLE SHELL Ø52MM TAPER SIZE 3

Model Number	321.03.352
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per comp (b)(4) - initial report.Additional information, including operative notes, x-rays and medical history of the patient, has been requested in order to progress with the investigation of this event.Available information will be detailed in a supplemental report.The appropriate device details have been requested.The relevant device manufacturing records will be identified and reviewed.Conclusions will be provided in a supplemental report.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 occured 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 and metafix revision of all parts after approximatively 1 month due to infection.
Additional Manufacturer Narrative
Per (b)(4) - final report.Additional information, including operative notes, x-rays and medical history of the patient, has been requested in order to progress with the investigation of this event.However, the reporter does not have access to any of this information.The appropriate devices details have been provided and the relevant device manufacturing and sterilisation records have been identified and reviewed.The devices were manufactured, packaged and sterilised according to specifications at the time of manufacture.The cleaning method, the sterilization method and sterile barrier system used to package our devices have a long history of safe and effective use at corin for a wide range of orthopedic devices and has been validated in accordance with the relevant standards.Infection is a known complication with any invasive surgery.Based on the above, no further investigation can be conducted.The root cause is not determined.Corin consider now this case 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 occured 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 and metafix revision of all parts after approximatively 1 month due to infection.

• Brand Name: TRINITY
• Common Device Name: TRINITY MULTI HOLE SHELL Ø52MM TAPER SIZE 3
• 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: 23265272
• Report Number: 9614209-2025-00593
• Device Sequence Number: 21377663
• Product Code: LWJ
• UDI-Device Identifier: 05055196927476
• UDI-Public: 05055196927476
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093472
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 321.03.352
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 592145
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• 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: METAFIX / STEM: 579.0102 LOT 564980; METAFIX / STEM: 579.0102 LOT 564980; TRINITY / HEAD: E321.228 LOT 598930; TRINITY / HEAD: E321.228 LOT 598930; TRINITY / INSERT: 325.03.040 LOT 598148; TRINITY / INSERT: 325.03.040 LOT 598148; TRINITY / LINER: 321.03.536 LOT 598000; TRINITY / LINER: 321.03.536 LOT 598000
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 130 KG