BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METAFIX

    MDR report key: 16396999 · Received February 17, 2023

    Report

    Report Number
    9614209-2023-00159
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    February 14, 2023
    Report Date
    May 16, 2023
    Manufacturer
    CORIN LTD
    Product Code
    LZO
    PMA / PMN Number
    K082525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FINAL REPORT. ADDITIONAL INFORMATION INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES (PRIMARY AND REVISION), WHAT WAS THE PATIENT DOING WHEN THE CUP MIGRATED THROUGH THE ACETABULUM, WHETHER THEY HAD EXPERIENCED ANY TRAUMA (SLIPS / FALLS ETC., WHETHER THERE WAS A REASON WHY THE METAFIX STEM WAS REVISED, WHETHER THE PATIENT ALSO EXPERIENCING ISSUES ON THE FEMORAL SIDE AND AN UPDATE ON THE PATIENT POST REVISION WAS REQUESTED IN ORDER TO PROGRESS WITH AN INVESTIGATION OF THIS EVENT, HOWEVER, THIS INFORMATION WAS NOT PROVIDED AND THUS THE SCOPE OF THE INVESTIGATION WAS LIMITED. THE POST PRIMARY ISSUE OCCURRED WITH A NON-CORIN DEVICE. THERE HAS BEEN NO REPORTED MALFUNCTION OF THE CORIN DEVICES. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. IT WAS FOUND THAT ALL FINISHED PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. THE REVISION OF THE CORIN DEVICES OCCURRED DUE TO A NON-CORIN CUP GOING THROUGH THE ACETABULAR WALL AT PRIMARY SURGERY. THERE HAS NOT BEEN A MALFUNCTION OR DETERIORATION IN THE EFFECTIVENESS OF A CORIN DEVICE. 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 THIS DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    CASE- (B)(4) INITIAL REPORT: ADDITIONAL INFORMATION INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES (PRIMARY AND REVISION), WHAT WAS THE PATIENT DOING WHEN THE CUP MIGRATED THROUGH THE ACETABULUM, WHETHER THEY HAD EXPERIENCED ANY TRAUMA (SLIPS / FALLS ETC., WHETHER THERE WAS A REASON WHY THE METAFIX STEM WAS REVISED, WHETHER THE PATIENT ALSO EXPERIENCING ISSUES ON THE FEMORAL SIDE AND AN UPDATE ON THE PATIENT POST REVISION HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH AN INVESTIGATION OF THIS EVENT, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE POST PRIMARY ISSUE OCCURRED WITH A NON-CORIN DEVICE. THERE HAS BEEN NO REPORTED MALFUNCTION OF THE CORIN DEVICES. 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 THIS DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    METAFIX / TRINITY REVISION OF THE STEM AND BIOLOX DELTA CERAMIC HEAD AFTER 8 DAYS DUE TO A NON-CORIN CUP MIGRATING THROUGH THE ACETABULUM. A NON-CORIN LINER WAS ALSO REVISED.

    Description of Event or Problem · 0

    METAFIX / TRINITY REVISION OF THE STEM AND BIOLOX DELTA CERAMIC HEAD AFTER 8 DAYS DUE TO A NON-CORIN CUP MIGRATING THROUGH THE ACETABULUM. A NON-CORIN LINER WAS ALSO REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126213 METAFIX METAFIX HIP STEM LZO CORIN LTD 579.1004 450576

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention| H BIOLOX DELTA CERAMIC HEAD: 104.3615, 454375| BIOLOX DELTA CERAMIC HEAD: 104.3615, 454375