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

Model Number	104.3200
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	05/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision of the ecima liner and biolox delta ceramic head after approximately 7 months and 2 weeks due to dislocation.
Additional Manufacturer Narrative
Per -10448 initial report.Additional information including, confirmation of the primary surgery date, post primary and pre revision x-rays, operative notes (primary and revision), patient activity level and medical history, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary, what the patient was doing at the time of the dislocation, what was implanted during the revision and an update on the patient following the 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 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: additional information including, confirmation of the primary surgery date, post primary and pre revision x-rays, operative notes (primary and revision), patient activity level and medical history, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary, what the patient was doing at the time of the dislocation, what was implanted during the revision and an update on the patient following the revision, was 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 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.Based on the available information, no further investigation can be conducted and the root cause of the reported dislocation could not be determined.Therefore, this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.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 ecima liner and biolox delta ceramic head after approximately 7 months and 2 weeks due to dislocation.

• 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: 22024419
• Report Number: 9614209-2025-00494
• Device Sequence Number: 7109383
• Product Code: LZO
• UDI-Device Identifier: 05055196964341
• UDI-Public: 05055196964341
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/04/2025

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: 104.3200
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 530903
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2023
• 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: TRINITY ECIMA LINER: 322.02.832, (B)(6).; TRINITY ECIMA LINER: 322.02.832, (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female