MAUDE Adverse Event Report: Corin Ltd Trinity Dual Mobility; ECiMa insert size 3

Model Number	325.03.040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity dual mobility and paragon revision (with ops used in primary surgery) of all devices after approximatively 3 weeks due to infection.Note: the paragon stem gm08001-203-03 is not cleared in the usa.
Additional Manufacturer Narrative
Per comp (b)(4) - initial report additional information, including if there are other patient harms, operative notes, x-rays, patient activity level, weight and medical history, and if the patient followed correct post-op protocol, has been requested in order to progress with the investigation of this event.Available information will be detailed in a supplemental report.The appropriate device details have been requested.The relevant device manufacturing records will be identified and reviewed.Conclusions will be provided in a supplemental report.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 occured 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 Dual Mobility
• Common Device Name: ECiMa insert size 3
• 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: 50851396
• Report Number: 9614209-2026-00116
• Device Sequence Number: 9953846
• Product Code: LZO
• UDI-Device Identifier: 05055343893524
• UDI-Public: 05055343893524
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170359
• 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
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 325.03.040
• Device Catalogue Number: Not applicable
• Device Lot Number: 627045
• 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: 09/07/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2026
• 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: 104.2810 Lot 631089; OPS Femoral Guide: 1250-0100, WDF_DZ_46503; Paragon / Stem: GM08001-203-03 Lot 619479; Trinity / Cup: 321.03.352 Lot 617506; Trinity DM / CoCr liner: 321.03.536 Lot 627628
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male