MAUDE Adverse Event Report: Corin Ltd Trinity; Multi Hole Shell Ø54mm Taper Size 4

Model Number	321.04.354
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity biolox delta revision (ops used in primary) of the cup, liner and head after approximatively 1 month due to misalignment/malalignment.
Additional Manufacturer Narrative
Per (b)(4) initial report.Additional information, including patient activity level, weight and medical history, post primary and pre-revision x-rays, operative notes (primary and revision), whether the patient experienced any slips / falls or other trauma post primary surgery, whether the patient followed 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: Trinity
• Common Device Name: Multi Hole Shell Ø54mm Taper Size 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 GL71Y J; UK GL71YJ
• Manufacturer Contact: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 50153121
• Report Number: 9614209-2026-00096
• Device Sequence Number: 9103323
• Product Code: LZO
• UDI-Device Identifier: 05055343870617
• UDI-Public: 05055343870617
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122305
• 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: Distributor
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: 321.04.354
• Device Catalogue Number: Not applicable
• Device Lot Number: 612716
• 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: 08/03/2026
• Initial Report FDA Received Date: 08/06/2026
• 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: Biolox Delta / Ceramic head: 104.4015 lot: 596990.; OPS Acetabular Guide: 1248-0500, PFW_ISC_95200.; OPS Femoral Guide: 1250-0100, PFW_ISC_95200.; OPS Insight: 1200-0000, PFW_ISC_95200; Trinity / Liner: 322.04.940 lot: 614999.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female