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

Model Number	104.3610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient age, weight, activity level and medical history, when did the pain start, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery 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.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.
Event or Problem Description
Trinity revision of the biolox delta ceramic head due to pain after approximately 2 years and 7 months.It was believed that the metafix stem was loose and thus a revision scheduled.Stem was not identified as loose intra-op at the revision and thus the head was changed and patient closed.
Additional Manufacturer Narrative
Per comp (b)(4) final report.Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient age, weight, activity level and medical history, when did the pain start, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery and an update on the patient post revision was requested in order to progress with the investigation of this event, however, this information could not be provided and thus the scope of this investigation was limited.The appropriate device details 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.Based on the available information, the root cause of the reported pain could not be determined and thus 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 head due to pain after approximately 2 years and 7 months.It was believed that the metafix stem was loose and thus a revision scheduled.Stem was not identified as loose intra-op at the revision and thus the head was changed and patient closed.

• Brand Name: BIOLOX DELTA
• Common Device Name: TRINITY ACETABULAR HIP SYSTEM WITH HXLPE LINERS (BIOLOX DELTA CERAMIC 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: 23083532
• Report Number: 9614209-2025-00576
• Device Sequence Number: 9738222
• 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: 2023
• 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): 11/22/2025

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: 104.3610
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 511891
• 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: 05/25/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male