BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM SCREW LOW PROFILE 5X40MM

    MDR report key: 6115370 · Received November 18, 2016

    Report

    Report Number
    0001825034-2016-04756
    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: 586970. CONCOMITANT MEDICAL PRODUCT - BIOMET M2A CUP CATALOG#: 15-105058 LOT#: 533170; BIOMET FEMORAL STEM CATALOG#: 11-103207 LOT#: 900190. THIS REPORT IS NUMBER 2 OF 3 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-02878, 04756 AND 04767).

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBER UPDATED TO K991807.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT HIP REVISION PROCEDURE, AN ACETABULAR SCREW FRACTURED UPON REMOVAL FROM THE CUP. A FRAGMENT OF THE PROXIMAL PORTION OF THE SCREW WAS RETAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763862 TITANIUM SCREW LOW PROFILE 5X40MM PROSTHESIS, SHOULDER KWT BIOMET ORTHOPEDICS N/A 581380

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention| S