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

Model Number	104.3605
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision (and washout) of the biolox delta ceramic head from the right hip in a bi-lateral patient after approximately 1 month due to infection.
Additional Manufacturer Narrative
Per comp -(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma and 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 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 comp -(b)(4) final report.Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma and an update on the patient post revision was requested in order to progress with the investigation of this event, however, the reporter confirmed that this information 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 releaved no product non-conformity or deviation from process that would have caused or contributed to this event.Based on the above, no further investigation can be conducted.Infection is a known complication with any invasive surgery and the reported devices were manufactured, packed and sterilised in accordance with the relevant standards.Thus, the root cause of the reported infection has not been linked to the devices and 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 (and washout) of the biolox delta ceramic head from the right hip in a bi-lateral patient after approximately 1 month due to infection.

• Brand Name: BIOLOX DELTA
• Common Device Name: TRINITY 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: 24000758
• Report Number: 9614209-2026-00002
• Device Sequence Number: 10398328
• Product Code: LZO
• UDI-Device Identifier: 05055196964389
• UDI-Public: 05055196964389
• 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): 03/18/2026

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: 104.3605
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 603728
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2025
• 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: 52 YR
• Patient Sex: Male