MAUDE Adverse Event Report: CORIN LTD TRINITY; BIOLOX DELTA FEMORAL HEAD

Model Number	104.4015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (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 did the patient follow correct post-op protocol? what was the patient doing at the time of the dislocations? did the patient experience any slips / falls or other trauma post primary surgery? 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 relevant device manufacturing records will be identified and reviewed.Please note: this report is filed with the fda due to an adverse event experience with a device that is similar to those paced on the market in the usa, however, this event occured oustide of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor cause or contributed to this event.
Event or Problem Description
Trinity revision (ops used in primary) of the biolox delta ceramic head after approximately 2 years and 6 months due to dislocation.

• Brand Name: TRINITY
• Common Device Name: BIOLOX DELTA FEMORAL HEAD
• 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: 24902860
• Report Number: 9614209-2026-00049
• Device Sequence Number: 21335131
• Product Code: LZO
• UDI-Device Identifier: 05055196926998
• UDI-Public: 05055196926998
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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: 104.4015
• Device Catalogue Number: N/A
• Device Lot Number: 537918
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2023
• 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: OPSINSIGHT: 1200-0000, HIC_RO_87788
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male