MAUDE Adverse Event Report: CORIN LTD TRINITY; TRINITY-I MULTI HOLE SHELL Ø50MM TAPER SIZE 3

Model Number	321.03.350
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision after approximatively 2 years and 11 months due to loosening of the cup and potential infection.
Additional Manufacturer Narrative
Per comp (b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient weight, activity level and medical history, whether the patient followed correct post-op protocol, if the patient experienced any 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 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) - final report.Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient weight, activity level and medical history, whether the patient followed correct post-op protocol, if the patient experienced any trauma and an update on the patient post revision, has been requested in order to progress with the investigation of this event.However, this information was not available.The appropriate devices details have been provided and the relevant device manufacturing and sterilisation records have been identified and reviewed.The devices were manufactured, packaged and sterilised according to specifications at the time of manufacture.Based on the available information, the root cause of the reported loosening and potential infection 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 after approximatively 2 years and 11 months due to loosening of the cup and potential infection.

• Brand Name: TRINITY
• Common Device Name: TRINITY-I MULTI HOLE SHELL Ø50MM TAPER SIZE 3
• 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: 23755930
• Report Number: 9614209-2025-00626
• Device Sequence Number: 21180410
• Product Code: LZO
• UDI-Device Identifier: 05055343870600
• UDI-Public: 05055343870600
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122305
• 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): 02/25/2026

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: 321.03.350
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 508141
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2022
• 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: 104.2805 LOT 510750.; TRINITY / HEAD: 104.2805 LOT 510750.; TRINITY / INSERT: 325.03.040 LOT 513622.; TRINITY / INSERT: 325.03.040 LOT 513622.; TRINITY / LINER: 321.03.536 LOT 509029.; TRINITY / LINER: 321.03.536 LOT 509029.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female