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

Model Number	104.4010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per comp (b)(4) initial report - the reporter has stated that they cannot provide any further information.The relevant device manufacturing and sterilisation 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 on the usa.The submission of this report does not constitute that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
Additional Manufacturer Narrative
Per (b)(4) initial report.The reporter has stated that they cannot provide any further information.The appropriate device details were provided and the relevant device manufacturing and sterilisation records have identified and reviewed.Review of these records revealed no product non-conformity or deviation from process that would have caused or contributed to the reported infection.Based on the above, no further investigation can be conducted.Infection is a known risk with any invasive surgery.Therefore, this case is now considered closed.The root cause of the infection could not be determined.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 on the usa.The submission of this report does not constitute that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
Event or Problem Description
Trinity washout / debridement and revision of the biolox delta ceramic head after 3 weeks and 4 days due to infection.The reporter has stated that no other information is available at the time.
Event or Problem Description
Trinity washout / debridement and revision of the biolox delta ceramic head after 3 weeks and 4 days due to infection.The reporter has stated that no other information is available at the time.

• Brand Name: BIOLOX DELTA
• Common Device Name: BIOLOX DELTA FEMORAL HEADS
• 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: 23705387
• Report Number: 9614209-2025-00617
• Device Sequence Number: 10649496
• Product Code: LZO
• UDI-Device Identifier: 05055196926981
• UDI-Public: 05055196926981
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 01/16/2026

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: 104.4010
• Device Catalogue Number: N/A
• Device Lot Number: 599871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2025
• Supplement Date Received by Manufacturer: 11/08/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 90 KG