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

Model Number	322.02.632
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) initial report the following additional information was requested from the reporter: post primary and pre revision x-rays operative notes (primary and revision) patient weight, activity level and medical history what was the patient doing at the time of the dislocations? did the patient experience any slips/ falls or other trauma post primary surgery? did the patient follow correct post-op protocol? an update on the patient post 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 occured outside the usa.The submission of this report does not constitute an admission that the device reporting entities respresentivitive or distributer caused or contributed to this event.
Event or Problem Description
Trinity revision of the cup and ecima liner after approximately 4 months due to dislocation.
Event or Problem Description
Trinity revision of the cup and ecima liner after approximately 4 months due to dislocation.
Additional Manufacturer Narrative
Per (b)(4) final report.The following additional information was requested from the reporter: post primary and pre revision x-rays.Operative notes (primary and revision).Patient weight, activity level and medical history.What was the patient doing at the time of the dislocations? did the patient experience any slips/ falls or other trauma post primnary surgery? did the patient follow correct post-op protocol? an update on the patient post revision.This information was not prvided and thus the scope of the investigation was lmited.The appropriate device tails were provided and the relevant device manufacturing and sterilisation records have been identified 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 reported dislocation 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 ofr further investigation.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 the usa.The submission of this report does not constitute an admission that the device reporting entities respresentivitive or distributer caused or contributed to this event.

• Brand Name: TRINITY
• Common Device Name: ACETABULAR SYSTEM WITH ECIMA 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: 22747296
• Report Number: 9614209-2025-00556
• Device Sequence Number: 9056819
• Product Code: OQI
• UDI-Device Identifier: 05055343870075
• UDI-Public: 05055343870075
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111481
• 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): 10/22/2025

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: 322.02.632
• Device Catalogue Number: N/A
• Device Lot Number: 583498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 CUP: 321.02.346, 574970; TRINITY CUP: 321.02.346, 574970
• Patient Age: 47 YR
• Patient Sex: Female