MAUDE Adverse Event Report: CORIN LTD. BIOLOX DELTA; TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS

Model Number	104.4015
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per - (b)(4) initial report: additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient activity level, weight and medical history, whether the patient followed correct post-op protocol and an update on the patient post revision, whether there was any damage to the liner, did the patient present with any symptoms (change in gait) 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 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 shell, biolox delta ceramic head and biolox delta ceramic liner after approximatively 12 years due to reported edge loading of the ceramic 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) initial report.Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient activity level, weight and medical history, whether the patient followed correct post-op protocol and an update on the patient post revision, whether there was any damage to the liner, did the patient present with any symptoms (change in gait) 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 were provided and all 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 available information, the root cause could not be confirmed and thus this case is 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 shell, biolox delta ceramic head and biolox delta ceramic liner after approximatively 12 years due to reported edge loading of the ceramic 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: BIOLOX DELTA
• Common Device Name: TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG 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: 22103400
• Report Number: 9614209-2025-00502
• Device Sequence Number: 7276570
• Product Code: LZO
• UDI-Device Identifier: 05055196926998
• UDI-Public: 05055196926998
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 08/18/2025

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: 06/01/2016
• Device Model Number: 104.4015
• Device Catalogue Number: N/A
• Device Lot Number: 196549
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2011
• 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: 321.04.440, (B)(6).; BIOLOX DELTA CERAMIC LINER: 321.04.440, (B)(6).; TRINITY SHELL: 320.04.356, (B)(6).; TRINITY SHELL: 320.04.356, (B)(6).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female