BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X20MM

    MDR report key: 2833195 · Received November 15, 2012

    Report

    Report Number
    0001825034-2012-02415
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    August 29, 2012
    Report Date
    November 9, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK991807
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "BENDING OR FRACTURE OF THE IMPLANT." ONE DAMAGED SCREW AND THE HEAD PORTION OF ONE FRACTURED SCREW WERE RETURNED FOR EVALUATION. IT CANNOT BE DETERMINED WHICH SCREW BELONGS TO WHICH LOT. EVALUATION OF THE RETURNED SCREWS CONFIRMED THAT ONE SCREW HAD FRACTURED, BUT THE FRACTURE SURFACE APPEARED TO HAVE BEEN HEAVILY DAMAGED POST-FRACTURE; THEREFORE THE FRACTURE MODE AND INITIATION SITE COULD NOT BE DETERMINED. THIS REPORT IS NUMBER 4 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01290, 01291, 01292, 02415 & 02416).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 ALLEGEDLY DUE TO PAIN AND SUSPECTED PSEUDOTUMOR. IT WAS REPORTED THAT THE SURGEON NOTED DURING THE REVISION THAT TWO ACETABULAR SCREWS WERE FRACTURED. ALL COMPONENTS WERE REMOVED AND REPLACED; HOWEVER, A PORTION OF ONE OF THE FRACTURED ACETABULAR SCREWS ALLEGEDLY REMAINS IN THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI LOW PROFILE SCREW 6.5X20MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 737890

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R