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

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	Bone Fracture(s) (1870)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision of the biolox delta ceramic head on the same day as primary surgery due to bone fracture which was sustained in surgery.
Additional Manufacturer Narrative
(b)(4) initial report.Additional information, including post-op x-rays, operative notes, patient weight, activity level and medical history, whether the patient experienced any slips / falls or other trauma post primary surgery, whether it is known what may have caused the fracture intra-op, whether the patient followed correct post-op protocol and an update on the patient 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 record 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 post-op x-rays, operative notes, patient weight, activity level and medical history, whether the patient experienced any slips / falls or other trauma post primary surgery, whether it is known what may have caused the fracture intra-op, whether the patient followed correct post-op protocol and an update on the patient was requested in order to progress with the investigation of this event, however, this information was not 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 assocaited 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 intra-op bone fracture and subsequent revision 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 dual mobility revision of the biolox delta ceramic head and ecima insert on the same day as primary surgery due to bone fracture which was sustained in surgery.

• Brand Name: BIOLOX DELTA
• Common Device Name: BIOLOX DELTA FEMORAL 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: 23825311
• Report Number: 9614209-2025-00620
• Device Sequence Number: 13083323
• 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): 02/18/2026

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: 104.2805
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 608545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRINITY DM ECIMA INSERT: 325.03.040, 604856.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown