MAUDE Adverse Event Report: CORIN LTD BIOLOX DELTA; ACETABULAR HIP SYSTEM WITH HXLPE LINERS (BIOLOX DELTA CERAMIC HEAD)

Model Number	104.3610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision of the biolox delta ceramic head after approximately 1 month and 1 week due to infection.
Additional Manufacturer Narrative
Per comp - (b)(4) initial report.The reporter has stated that they are unable to provide any further details regarding the event.An update on the patient has been requested.The appropriate device details have been provided and 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 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.
Additional Manufacturer Narrative
Per (b)(4) final report.The reporter stated that they are unable to provide any further details regarding the event.An update on the patient was requested but could not be provided.The appropriate device details were provided and the relevant device manufacturing and sterilisation records have been identified and reviewed.Review of these records revealed no product non-conformity or deviation from process.Based on the above, no further investigation can be conducted.The reported device was manufactured, packed and sterilised in accordance with the relevant standards and specifications and thus the root cause of the reported infection has not been linked to the device and is considered as external.Infection is a known risk with any invasive surgery.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 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.
Event or Problem Description
Trinity revision of the biolox delta ceramic head after approximately 1 month and 1 week due to infection.

• Brand Name: BIOLOX DELTA
• Common Device Name: ACETABULAR HIP SYSTEM WITH HXLPE LINERS (BIOLOX DELTA CERAMIC 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: 23861653
• Report Number: 9614209-2025-00623
• Device Sequence Number: 21157023
• Product Code: LZO
• UDI-Device Identifier: 05055196964396
• UDI-Public: 05055196964396
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: 104.3610
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 599632
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 75 KG