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

Model Number	322.04.636
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision of the ecima liner after approximately 3 years and 11 months due to instability.
Additional Manufacturer Narrative
(b)(4) initial report.Additional information including: a post primary x-ray.Operative notes (primary and revision).Patient activity level, weight and medical history.Did the patient follow the correct post-op protocol? did the patient experience any slips / falls or other trauma post primary surgery? were there any fixation concerns during the primary surgery? an update on the patient post revision have been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon the 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 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,.
Additional Manufacturer Narrative
Per (b)(4) final report.Please note: length of time devices implanted has been corrected in section b.5 from 3 years 11 months to 3 years and 7 months.Additional information including: - a post primary x-ray - operative notes (primary and revision), - patient activity level, weight and medical history.- did the patient follow the correct post-op protocol? - did the patient experience any slips / falls or other trauma post primary surgery? - were there any fixation concerns during the primary surgery? - an update on the patient post revision.Was requested in order to progress with the investigation of this event, however none of the requested information was provided and thus the scope of the investigation is limited.The appropriate device details were provided and the relevant device manufacturing records were 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.Corin has not stated compatibility between the trinity cup / liner and bioball heads and thus the primary usage is off-label and may have caused or contributed to the instability.This case is now considered closed, however, should any additional information be provided then this case may be re-opened for 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 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 ecima liner after approximately 3 years and 7 months due to instability.

• Brand Name: TRINITY
• Common Device Name: ACETABULAR HIP 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: 23826218
• Report Number: 9614209-2025-00630
• Device Sequence Number: 12010128
• Product Code: OQI
• UDI-Device Identifier: 05055343869574
• UDI-Public: 05055343869574
• 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: 2022
• 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): 02/18/2026

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: 322.04.636
• Device Catalogue Number: N/A
• Device Lot Number: 494705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2021
• Is the Device Labeled for Single Use? (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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown