MAUDE Adverse Event Report: CORIN LTD MOBILIT; CUP CEMENTLESS CUP TI + HAP

Model Number	HDM654
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) - initial report.Additional information, including confirmation of the explanted parts, confirmation of the date of revision, lot codes, operative notes, x-rays and medical history of the patient, 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.
Event or Problem Description
Mobilit revision of the cup, ecima insert and head after approximatively 9 days due to fracture at the level of the acetabulum.Note: this is a regularization within the framework of a clinical study following a change in our event monitoring process of sae from clinical study.

• Brand Name: MOBILIT
• Common Device Name: CUP CEMENTLESS CUP TI + HAP
• Manufacturer (Section D): CORIN LTD; the corinium centre; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD; the corinium centre; gloucestershire GL71Y J; UK GL71YJ
• Manufacturer Contact: franck didier ; the corinium centre; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 24998980
• Report Number: 9614209-2026-00053
• Device Sequence Number: 13200887
• Product Code: LZO
• UDI-Device Identifier: 05056139200908
• UDI-Public: 05056139200908
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K191831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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: HDM654
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 597305
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2025
• 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 / INSERT: HDM2854 LOT 608833.; TRINITY / HEAD: E321.128 LOT 607733.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 162 LB