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

Model Number	104.3200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision of the ecima liner and biolox delta ceramic head after approximately 1 month due to the patient experiencing a femoral fracture following a fall.
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, 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 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 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 the event.
Event or Problem Description
Trinity revision of the ecima liner and biolox delta ceramic head after approximately 1 month due to the patient expierencing a femoral fracture following a fall.
Additional Manufacturer Narrative
(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 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, however none of these details were able to be provided.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.The femoral fracture was due to the patient experiencing a fall and is not linked to the device design or performance, no further investigation is required 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 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 the event.

• Brand Name: BIOLOX DELTA
• 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: 24454590
• Report Number: 9614209-2026-00032
• Device Sequence Number: 18634059
• Product Code: LZO
• UDI-Device Identifier: 05055196964341
• UDI-Public: 05055196964341
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/14/2026

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: 104.3200
• Device Catalogue Number: N/A
• Device Lot Number: 565822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• 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 ECIMA LINER: 322.02.932, 602936; TRINITY ECIMA LINER: 322.02.932, 602936
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 58 KG