BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ B HI 60MM

    MDR report key: 3676460 · Received March 13, 2014

    Report

    Report Number
    0001825034-2014-01644
    Event Type
    Injury
    Date Received
    March 13, 2014
    Date of Event
    January 30, 2014
    Report Date
    October 23, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND WAS FOUND TO HAVE BEEN MANUFACTURED WITHIN SPECIFICATIONS. DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED AS THE SCREW HAD A BROKEN SCREW REMOVAL TOOL FROM A DIFFERENT MANUFACTURER IN THE SCREW HEAD. REMOVAL OF SCREW WITH THIS TECHNIQUE IS OFF MARKET. THE SCREW HEAD WAS STRIPPED AND HAD A BROKEN REMOVAL TIP. LIKE PRODUCT FROM SHELF WAS TESTED WITH NO ISSUES THREADING THE SCREW IN AND OUT.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-01643 / 01645).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION PROCEDURE ON (B)(4) 2014. DURING THE PROCEDURE, THE LOCKING SCREW STRIPPED WHILE THE PROXIMAL BODY WAS ASSEMBLED TO THE STEM. SURGEON ATTEMPTED TO UTILIZE ANOTHER SCREW BUT THE SCREW STRIPPED. SUBSEQUENTLY, A SCREW REMOVAL TOOL FRACTURED DURING THE PROCEDURE. A NEW STEM AND PROXIMAL BODY WERE UTILIZED TO COMPLETE THE PROCEDURE. A DELAY OVER 30 MINUTES OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION PROCEDURE ON (B)(6) 2014 DUE TO A FEMUR FRACTURE NOT IMPLANT RELATED. DURING THE PROCEDURE, THE LOCKING SCREW WOULD NOT ENGAGE AND STRIPPED WHILE THE PROXIMAL BODY WAS ASSEMBLED TO THE STEM. SUBSEQUENTLY, A COMPETITOR SCREW REMOVAL TOOL FRACTURED DURING THE PROCEDURE. SURGEON SUCCESSFULLY ENGAGED THE INITIAL LOCKING SCREW IN PLACE AND A NEW STEM AND PROXIMAL BODY WERE UTILIZED TO COMPLETE THE PROCEDURE. A DELAY OVER 30 MINUTES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150025 ARCOS CON SZ B HI 60MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 851980

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R