MAUDE Adverse Event Report: CORIN LTD TRINITY; ACETABULAR SYSTEM WITH HXLPE LINERS

Model Number	104.4000
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) initial report: the reporter confirmed that no additional information could be provided due to patient confidentiality.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 experience 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 revision of ceramic liner, ceramic head and screws due to pain/ impingement please note: the trinity biolox delta ceramic liner subject to this report is not cleared for sale or distribution in the usa and this event occured outside of the usa.Trinity screws and biolox delta ceramic head were also revised, these devices are cleared for sale/ distribution in the usa.
Additional Manufacturer Narrative
Per (b)(4) initial report.The reporter confirmed that no additional information could be provided due to patient confidentiality.The relevant device manufacturing records were provided and the relevant device manufacturing records have been identfied and reviewed.All parts associated with these records 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 impingement could not be determined, therefore, this case is now considered closed.However, should any additional information be provided then this case may be re-opened for further inevstiagtion.Please note: this report is filed with the fda due to an adverse event experience 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 consititute 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 ceramic liner, ceramic head and screws due to pain/ impingement.Please note: the trinity biolox delta ceramic liner subject to this report is not cleared for sale or distribution in the usa and this event occured outside of the usa.Trinity screws and biolox delta ceramic head were also revised, these devices are cleared for sale/ distribution in the usa.

• Brand Name: TRINITY
• Common Device Name: ACETABULAR SYSTEM WITH HXLPE LINERS
• 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: 23837927
• Report Number: 9614209-2025-00634
• Device Sequence Number: 17413548
• Product Code: LZO
• UDI-Device Identifier: 05055196926967
• UDI-Public: 05055196926967
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 03/03/2025

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
• Device Expiration Date: 04/13/2021
• Device Model Number: 104.4000
• Device Catalogue Number: N/A
• Device Lot Number: 332579
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2016
• 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 BIOLOX CERAMIC LINER: 321.05.440, 363697.; TRINITY BIOLOX CERAMIC LINER: 321.05.440, 363697.; TRINITY SCREW: 321.020, 404185.; TRINITY SCREW: 321.020, 404185.; TRINITY SCREW: 321.020, 404185.; TRINITY SCREW: 321.020, 404185.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 106 KG