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

Model Number	104.2805
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per comp - 523 initial report additional information, including 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 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 report, 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 have been identified and will be reviewed.Please note: this report has been 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 dual mobility revision of the ecima insert and biolox delta ceramic head after approximately 7 months due to instability.
Event or Problem Description
Trinity dual mobility revision of the ecima insert and biolox delta ceramic head after approximately 7 months due to instability.
Additional Manufacturer Narrative
Per (b)(4) final report.Additional information, including 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 was implanted at the revision and an update on the patient post revision was requested in order to progress with the investigation of this event.It was confirmed that the patient had not followed correct post-op protocols.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.Based on the above, it has been concluded that the instability occurred as a result of the patient not following correct post-op protocol and was not due to the device design or performance.Therefore, no further investigation is required and this case is now considered closed.Please note: this report has been 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: 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: 22911225
• Report Number: 9614209-2025-00564
• Device Sequence Number: 13023616
• Product Code: LZO
• UDI-Device Identifier: 05055196964327
• UDI-Public: 05055196964327
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103120
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: 104.2805
• Device Catalogue Number: N/A
• Device Lot Number: 579829
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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 DM ECIMA INSERT: 325.04.042, (B)(6).; TRINITY DM ECIMA INSERT: 325.04.042, (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male