MAUDE Adverse Event Report: Corin Ltd BIOLOX Delta; Trinity Acetabular Hip System with HXLPE Liners (BIOLOX Delta Ceramic Head)

Model Number	104.3605
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision of the cup, ecima liner and biolox delta ceramic head after approximately 6 months due to dislocation / cup malalignment.
Additional Manufacturer Narrative
Per comp - 3630 initial report.Additional information, including patient activity level, weight and medical history, post primary and pre-revision x-rays, operative notes (primary and revision), was the original cup placement at primary surgery malaligned or has there been movement / displacement of the cup post-primary, did the patient present with any symptoms or was the cup malalignment identified during routine follow-up, did the patient experience any slips / falls or other trauma post primary surgery, did the patient follow correct post-op protocol 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 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.

• 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: 50069288
• Report Number: 9614209-2026-00089
• Device Sequence Number: 13363227
• 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: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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: Not applicable
• Device Lot Number: 610690
• 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: 07/10/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Cup: 321.04.356, 593522.; Trinity ECiMa Liner: 322.04.936, 602946.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male