MAUDE Adverse Event Report: Corin Ltd MetaFix; MetaFix Femoral Stem

Model Number	579.1004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Metafix / trinity dual mobility revision of the stem, biolox delta ceramic head and ecima insert after approximately 1 year and 2 months due to a femoral peri-prosthetic fracture (patient experienced a fall).
Additional Manufacturer Narrative
Per comp - (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), did the patient follow correct post-op protocol, what was the patient doing at the time of the fall 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: MetaFix
• Common Device Name: MetaFix Femoral Stem
• 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: 50802561
• Report Number: 9614209-2026-00121
• Device Sequence Number: 10610481
• Product Code: LZO
• UDI-Device Identifier: 05055196900738
• UDI-Public: 05055196900738
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 579.1004
• Device Catalogue Number: Not applicable
• Device Lot Number: 523482
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/17/2026
• 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: 104.2810, 571257.; Trinity DM ECiMa Insert: 325.04.042, 522271.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male