MAUDE Adverse Event Report: CORIN LTD TRINITY; ACETABULAR SYSTEM

Model Number	321.02.348
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision of the cup, ecima liner, modular head and 2 screws following a fall which has made the primary hip unstable.
Additional Manufacturer Narrative
Per comp (b)(4).Initial report.Additional information, including: operative notes (primary and revision) patient age, activity level, weight and medical history.What the patient was doing at the time of the fall.Whether the patient followed correct post-op protocol.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 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 contribued to this event.
Additional Manufacturer Narrative
Per (b)(4) final report additional information, including: - operative notes (primary and revision).- patient age, activity level, weight and medical history.- what the patient was doing at the time of the fall.- whether the patient followed correct post-op protocol.- an update on the patient post revision.Has been requested in order to progress with the investigation of this event however, none of these details were provided.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.As the instability and subsequent revision were due to the patient experiencing a fall and not linked to the device design or performance, no further investigation is required and thus 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.
Event or Problem Description
Trinity revision of the cup, ecima liner, modular head and 2 screws following a fall which has made the primary hip unstable.

• Brand Name: TRINITY
• Common Device Name: ACETABULAR 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: 22911377
• Report Number: 9614209-2025-00568
• Device Sequence Number: 9055264
• Product Code: LWJ
• UDI-Device Identifier: 05055196927452
• UDI-Public: 05055196927452
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 321.02.348
• Device Catalogue Number: N/A
• Device Lot Number: 550022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 11/05/2025
• Date Device Manufactured: 03/11/2024
• 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 MOD HEAD: E321.132, (B)(6).; TRINITY COCR MOD HEAD: E321.132, (B)(6).; TRINITY ECIMA LINER: 322.02.932, (B)(6).; TRINITY ECIMA LINER: 322.02.932, (B)(6).; TRINITY SCREW: 321.020, (B)(6).; TRINITY SCREW: 321.020, (B)(6).; TRINITY SCREW: 321.040, (B)(6).; TRINITY SCREW: 321.040, (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 45 KG