MAUDE Adverse Event Report: CORIN LTD TRINITY; BIOLOX DELTA CERAMIC MODULAR HEAD Ø36MM 12/14 LONG +4

Model Number	104.3610
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) initial report.Additional information, including confirmation of the lot codes, 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 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 confirmation of the 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
Trinity revision of the head and liner after approximatively 9 years and 8 months due to dislocation.Note: the trinity liner 321.04.436 is not cleared in the usa.
Additional Manufacturer Narrative
Per comp - (b)(4) final report.Additional information, including confirmation of the lot codes, 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 and an update on the patient post revision has been requested in order to progress with the investigation of this event.However, the reporter did not communicate any information.The appropriate device details of the head were provided and the relevant device manufacturing record has been identified and reviewed.All parts associated with this record conformed to material and dimensional specification at the time of manufacture.Patient stickers are not available for old 2015 surgeries, unfortunately it is not possible to confirm the lot code of the liner.Based on the available information, the root cause of the reported dislocation could not be determined and thus 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.
Event or Problem Description
Trinity revision of the head and liner after approximatively 9 years and 8 months due to dislocation.Note: the trinity liner 321.04.436 is not cleared in the usa.

• Brand Name: TRINITY
• Common Device Name: BIOLOX DELTA CERAMIC MODULAR HEAD Ø36MM 12/14 LONG +4
• 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: 22904123
• Report Number: 9614209-2025-00566
• Device Sequence Number: 12766975
• Product Code: LZO
• UDI-Device Identifier: 05055196964396
• UDI-Public: 05055196964396
• 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: 2015
• 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): 11/13/2025

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 Expiration Date: 07/06/2020
• Device Model Number: 104.3610
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 317715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2015
• 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 / LINER: 321.04.436 LOT TO BE CONFIRMED; TRINITY / LINER: 321.04.436 LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female