MAUDE Adverse Event Report: CORIN LTD TRINITY; COCR MODULAR HEAD Ø28MM MEDIUM 0.0MM 12/14 EUROCONE TAPER

Model Number	E321.128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Mobilit and trinity revision of the polyethylene insert and cocr mod head after 1 month due to infection.Note 1: the mobilit insert hdm250 is not cleared in the usa.Note 2: this is a regularization within the framework of a clinical study following a change in our event monitoring process of sae from clinical study.
Additional Manufacturer Narrative
Per comp (b)(4) - initial report.Additional information including, operative notes, x-rays and medical patient information, 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 requested 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 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
• Common Device Name: COCR MODULAR HEAD Ø28MM MEDIUM 0.0MM 12/14 EUROCONE TAPER
• Manufacturer (Section D): CORIN LTD; the corinium centre; gloucestershire GL71Y J; UK GL71YJ
• Manufacturer (Section G): CORIN LTD; the corinium centre; cirencester, gloucestershire GL7 I YJ; UK GL7 IYJ
• Manufacturer Contact: franck didier ; the corinium centre; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 24965861
• Report Number: 9614209-2026-00051
• Device Sequence Number: 10455888
• Product Code: MEH
• UDI-Device Identifier: 05055196933743
• UDI-Public: 05055196933743
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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: E321.128
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 564763
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2024
• 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: MOBILIT / PE INSERT: HDM250 LOT 561301
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 72 KG