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

Model Number	104.3615
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) initial report.Additional information including: pre-revision and post primary x-rays.Operative notes (primary and revision).Patient activity level, weight and medical history.Did the patient follow the correct post-op protocol? did the patient experience any slips / falls or other trauma post primary surgery? were there any fixation concerns during the 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 placed on the market in the usa, however, this event occured 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
Metafix/ trinity revision (ops used in primary) of the stem, ecima liner and the biolox delta ceramic head after 4 years due to instability.

• 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: 25094097
• Report Number: 9614209-2026-00056
• Device Sequence Number: 15950114
• Product Code: LZO
• UDI-Device Identifier: 05055196968349
• UDI-Public: 05055196968349
• 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: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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: 104.3615
• Device Catalogue Number: N/A
• Device Lot Number: 484888
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2021
• 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: METAFIX STEM: 579.2103, 488885; METAFIX STEM: 579.2103, 488885.; OPS FEMORAL GUIDE: 1250-0100, WOO_SM_59128; OPS FEMORAL GUIDE: 1250-0100, WOO_SM_59128.; OPS INSIGHT: 1200-0000, WOO_SM_59128; OPS INSIGHT: 1200-0000, WOO_SM_59128.; TRINITY ECIMA LINER: 322.03.636, 499266; TRINITY ECIMA LINER: 322.03.636, 499266.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male