BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM SCREW LOW PROFILE 5X40MM

    MDR report key: 6115378 · Received November 18, 2016

    Report

    Report Number
    0001825034-2016-04767
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    February 3, 2015
    Report Date
    March 6, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWT
    PMA / PMN Number
    PK991807
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 OR DEVIATION. POSSIBLE LOT NUMBER: 581380. CONCOMITANT MEDICAL PRODUCT - BIOMET M2A CUP CATALOG#: 15-105058 LOT#: 533170; BIOMET FEMORAL STEM CATALOG#: 11-103207 LOT#: 900190. THIS REPORT IS NUMBER 3 OF 3 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-02878, 04756 AND 04767).

    Additional Manufacturer Narrative · 1

    THE 510K NUMBER CHANGED TO K991807.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE SCREW BECAME STRIPPED DURING REMOVAL. THE SCREW WAS UNABLE TO BE REMOVED. SCREW REMOVAL INSTRUMENTATION FRACTURED IN THE HEAD OF THE SCREW, AND THE ACETABULAR CUP WAS LEFT IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763865 TITANIUM SCREW LOW PROFILE 5X40MM PROSTHESIS, SHOULDER KWT BIOMET ORTHOPEDICS N/A 586970

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention