MAUDE Adverse Event Report: CORIN LTD METAFIX; METAFIX FEMORAL STEM

Model Number	579.0003
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Metafix revision after approximately 10 years due to fracture of the stem.
Additional Manufacturer Narrative
Per (b)(4) initial report.Additional information including, were any other corin implants revised, post promary and pre revision x-rays, operative notes (primary and revision), patient age, activity level, patient medical history, did the patient follow the correct post-op protocl 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 an supplemental report upon completion of the investigation.The relevant device manufacturing records will be indentified 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 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.
Additional Manufacturer Narrative
Per (b)(4) final report.Additional information including, were any other corin implants revised, post promary and pre revision x-rays, operative notes (primary and revision), patient age, activity level, patient medical history, did the patient follow the correct post-op protocl and an update on the patient post revision were requested in order to progress with the investigation of this event.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimesnional specification at the time of manufacture.The investigation determined no device related reason for this metafix femoral neck failure.The stem was confirmed in specification as documented by the dhr.No clear root cause was determined, the ifu provides guidance to the surgeon regarding factors that may impact the product's lifetime, and warnings regarding situations which may threaten the success of the hip replacement, which includes obesity or excessive weight.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.
Event or Problem Description
Metafix revision after approximately 10 years due to fracture of the stem.

• 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: 22435782
• Report Number: 9614209-2025-00529
• Device Sequence Number: 19624041
• Product Code: LZO
• UDI-Device Identifier: 05055196900691
• UDI-Public: 05055196900691
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K082525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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 Expiration Date: 01/11/2020
• Device Model Number: 579.0003
• Device Catalogue Number: N/A
• Device Lot Number: 299220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 120 KG