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

Model Number	322.05.740
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision of the ecima liner after approximately 1 year and 9 months due to stability issues.
Additional Manufacturer Narrative
Per (b)(4) initial report.Additional information including: post primary and pre revision x-rays, operative notes (primary and revision) patient age, activity level, patient medical history.Did the patient follow the correct post-op protocol.Did the patient experience any slips/ falls or other trauma post primary? 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 an supplemental report upon completion of the investigation the relevant device manufacturing records will be identified and reviewed.Conclusions will be provided in a supplemental report.
Additional Manufacturer Narrative
Per (b)(4).Has been requested in order to progress with the investigation of this event, however this information could not be provided and thus the scope of the investigation was limited.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of the manufacture.Based on the available information, no further investigation can be conducted and the root cause of the reported instability 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 investigation.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 ecima liner after approximately 1 year and 9 months due to stability issues.

• Brand Name: TRINITY
• Common Device Name: ACETABULAR SYSTEM 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: 23220443
• Report Number: 9614209-2025-00592
• Device Sequence Number: 21009335
• Product Code: OQI
• UDI-Device Identifier: 05055343869710
• UDI-Public: 05055343869710
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K111481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/10/2025

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 Expiration Date: 09/24/2024
• Device Model Number: 322.05.740
• Device Catalogue Number: N/A
• Device Lot Number: 439878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female