MAUDE Adverse Event Report: Corin Ltd Trinity; BIOLOX delta Ceramic Modular Head Ø40mm 12/14 Medium 0

Model Number	104.4005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision (with ops used in primary) of the biolox delta ceramic liner and head after approximately 4 years and 5 months due to dislocation.Note: the trinity biolox delta ceramic liner 321.04.440 is not cleared in the usa.
Additional Manufacturer Narrative
Per (b)(4) - fda initial report.Additional information including patient information, post primary and pre-revision x-rays, operative notes (primary and revision), whether the patient followed correct post-op protocol, if the patient experienced any trauma, what was the patient doing at the time of the dislocation, 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.

• Brand Name: Trinity
• Common Device Name: BIOLOX delta Ceramic Modular Head Ø40mm 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: 50772566
• Report Number: 9614209-2026-00115
• Device Sequence Number: 10416613
• Product Code: LZO
• UDI-Device Identifier: 05055196926974
• UDI-Public: 05055196926974
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 104.4005
• Device Catalogue Number: Not applicable
• Device Lot Number: 467929
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Biolox Delta / Liner: 321.04.440 Lot 489609; OPS acetabular guide: 1248-0500, WHI_GS_52988; OPS femoral guide: 1250-0100,WHI_GS_52988; OPS insight: 1200-0000,WHI_GS_52988
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male