MAUDE Adverse Event Report: Corin Ltd Trinity Acetabular System; Biolox Delta Ceramic Modular Head Ø36mm 12/14 Medium 0

Model Number	104.3605
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4)5 final report the following information 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.- was the suspected infection confirmed? had the patient undergone any other recent procedures / treatments that could have caused the infection - patient age, activity level, weight and medical history - post primary and pre revision x-rays - operative notes (primary and revision) - did the patient follow correct post-op protocol? - an update on the patient following the revision however the reporter didn't respond.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.The ops device processing files were investigated which included reviewing ops processes, and ops femoral guide.No anomalies were observed in these records which may have caused or contributed to this event.Based on the above, no further investigation can be conducted and the root cause of the infection has not been linked to the devices.Infection is a known complication with any invasive surgery 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.

• Brand Name: Trinity Acetabular System
• Common Device Name: Biolox Delta Ceramic Modular Head Ø36mm 12/14 Medium 0
• 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: 50171386
• Report Number: 9614209-2026-00097
• Device Sequence Number: 15508020
• Product Code: LZO
• UDI-Device Identifier: 05055196964389
• UDI-Public: 05055196964389
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K110087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 104.3605
• Device Lot Number: 618266
• 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: 07/22/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OPS Femoral Guide: 1250-0100 lot SLU_WLT_26045; Trinity ECiMa Liner: 322.04.636 lot 616764
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male