MAUDE Adverse Event Report: CORIN LTD TRINITY-I; TRINITY-I ACETABULAR SHELL

Model Number	321.03.350
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) initial report.Corin are currently conducting an investigation into the root cause of this event, and information will be provided in a supplemental report upon 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 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 shell incorrectly labelled.This was identified prior to use, however, did cause surgery to be extended by approximately 50 minutes.There has been no other reported surgical or patient impact.
Additional Manufacturer Narrative
Per (b)(4) final report.Internal investigation concluded the manufacturing procedure / process as the root cause.A project has been initiated to implement corrective / preventative actions.Affected devices in the field were recalled.Please note: there was no affected devices in the us market.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.Review of these records revealed no product non-conformity or deviation from process that would have resulted in the reported event.Based on the above, no further investigation is required.Corin is confident that the corrective / preventative actions identified by the project team will negate a repeat of such events.Therefore, this case is now considered closed.Please note: this report is filed with the fda due to an 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 shell incorrectly labelled.This was identified prior to use, however, did cause surgery to be extended by approximately 50 minutes.There has been no other reported surgical or patient impact.

• Brand Name: TRINITY-I
• Common Device Name: TRINITY-I ACETABULAR SHELL
• 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: 24255799
• Report Number: 9614209-2026-00012
• Device Sequence Number: 18220064
• Product Code: LZO
• UDI-Device Identifier: 05055343870600
• UDI-Public: 05055343870600
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 321.03.350
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 603488
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2025
• 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-I SHELL: 321.02.346, 603932.; TRINITY-I SHELL: 321.02.346, 603932.
• Patient Sex: Unknown