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

Model Number	104.3605
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per comp-(b)(4) initial report.Additional information including: - post primary and pre revision x-rays, - operative notes (primary and revision).- patient age, activity level, patient medical history.- did the patient follow the correct post-op protocl.- 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 an supplemental report upon completion of the investigation.The relevant device manufacturing records will be indentified and reviewed.Conclusions will be provided in a supplemental report.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 biolox delta ceramic liner and head after approximately 4 months and 2 weeks due to fracture of the liner.Please note: the trinity biolox delta ceramic liner subject of this report is not cleared for sale or distribution in the usa and this event occurred outside of the usa.A biolox delta ceramic head was also revised, this device is cleared for sale /distribution in the usa.
Additional Manufacturer Narrative
Per (b)(4) final report.Additional information including: - post primary and pre revision x-rays, - operative notes (primary and revision), - patient age, activity level, patient medical history, - did the patient follow the correct post-op protocl, - an update on the patient post revision.Has been requested in order to progress with the investigation of this event, however none of the requested information was provided and thus the scope of the investigation is limited.The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed.All 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 fracture 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 biolox delta ceramic liner and head after approximately 4 months and 2 weeks due to fracture of the liner.Please note: the trinity biolox delta ceramic liner subject of this report is not cleared for sale or distribution in the usa and this event occurred outside of the usa.A biolox delta ceramic head was also revised, this device is cleared for sale /distribution in the usa.

• Brand Name: TRINITY
• Common Device Name: BIOLOX DELTA FEMORAL HEAD (TRINITY ACETABULAR HIP SYSTEM WITH HXLPE LINERS)
• 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: 23198147
• Report Number: 9614209-2025-00589
• Device Sequence Number: 15772650
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: N/A
• Device Lot Number: 586093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BIOLOX DELTA CERAMIC LINER: 321.05.436, 473910.; BIOLOX DELTA CERAMIC LINER: 321.05.436, 473910.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male