MAUDE Adverse Event Report: CORIN LTD TRINITY; LINER (ECIMA) Ø40MM NEUTRAL 4MM EPW TAPER SIZE 4

Model Number	322.04.940
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision of the ecima liner and biolox delta ceramic head after approximately 2 years and 5 months due to dislocation.
Additional Manufacturer Narrative
Per comp 967: fda initial report.Additional information including x-rays, operative notes, patient weight, activity level and medical history, if the patient experienced any slips/ falls or other trauma and 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 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 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.
Additional Manufacturer Narrative
Per (b)(4)- fda final report.Additional information including x-rays, operative notes, patient weight, activity level and medical history, if the patient experienced any slips/ falls or other trauma and an update on the patient post revision, has been requested in order to progress with the investigation of this event.The reporter confirmed that the surgeon was unable to replicate the dislocation prior to performing the revision surgery.In addition, the surgeon has reported that the patient has presented with posterior dislocation post op 1 month.No more information was available.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 manufacture.Based on the available information, the root cause of the reported dislocation could not be determined 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 ecima liner and biolox delta ceramic head after approximately 2 years and 5 months due to dislocation.

• Brand Name: TRINITY
• Common Device Name: LINER (ECIMA) Ø40MM NEUTRAL 4MM EPW TAPER SIZE 4
• 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: 23198330
• Report Number: 9614209-2025-00588
• Device Sequence Number: 13259246
• Product Code: OQI
• UDI-Device Identifier: 05055343869888
• UDI-Public: 05055343869888
• 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: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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 Model Number: 322.04.940
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 499838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2022
• 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 / HEAD: 104.4005 LOT 521151; TRINITY / HEAD: 104.4005 LOT 521151
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female