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

Model Number	104.3605
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) initial report.Additional information, including, confirmation of the primary surgery date as the reporter stated (b)(6) 2023, however, on the ops portal it states primary surgery date as (b)(6) 2023, patient weight, activity level and medical history, 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 post primary surgery, what the patient was doing at the time of the dislocation, what was implanted at the revision 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.Upon receipt of the missing lot codes, 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 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
Metafix / trinity revision of the stem, ecima liner and biolox delta ceramic head after approximately 1 year and 10 months due to dislocation.
Event or Problem Description
Metafix / trinity revision of the stem, ecima liner and biolox delta ceramic head after approximately 1 year and 10 months due to dislocation.
Additional Manufacturer Narrative
Per (b)(4) final report.Additional information, including, confirmation of the primary surgery date as the reporter stated (b)(6) 2023, however, on the ops portal it states primary surgery date as (b)(6) 2023, patient weight, activity level and medical history, 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 post primary surgery, what the patient was doing at the time of the dislocation, what was implanted at the revision and an update on the patient post revision has been requested in order to progress with the investigation of this event, however, not all information could be provided and thus the scope of the investigation was limited.The surgeon stated that the patient fell in the bath resulting in dislocation.The appropriate device details have been provided and the relevant device manufacturing records have been 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 dislocation.Based on the above, no further investigation can be conducted and the root cause has been concluded to be a result of the patient fall and not linked to the device design or performance.Therefore, 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.

• Brand Name: BIOLOX DELTA
• Common Device Name: TRINITY ACETABULAR HIP SYSTEM WITH HXLPE LINERS (BIOLOX DELTA CERAMIC HEAD)
• Manufacturer (Section D): CORIN MEDICAL; 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: 22893000
• Report Number: 9614209-2025-00562
• Device Sequence Number: 8896893
• Product Code: LZO
• UDI-Device Identifier: 05055196964389
• UDI-Public: 05055196964389
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/12/2025

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: 537909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2023
• 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: 579.2004, (B)(6).; METAFIX STEM: 579.2004, (B)(6).; TRINITY ECIMA LINER: 322.04.736, (B)(6).; TRINITY ECIMA LINER: 322.04.736, UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male