BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERCHANGEABLE HEAD-50 MM- DELRIN

    MDR report key: 6785866 · Received August 10, 2017

    Report

    Report Number
    1833053-2017-00003
    Event Type
    Injury
    Date Received
    August 10, 2017
    Date of Event
    June 28, 2017
    Report Date
    August 10, 2017
    Manufacturer
    INNOMED, INC.
    Product Code
    HWB
    UDI-DI
    00840277104496
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION WAS RECEIVED BY THE CDRH ON 6/30/2017 WITH ASSIGNED MDR REPORT KEY (B)(4): A 50MM RADIOTRANSPARENT TRIAL FEMORAL HEAD BROKE UPON INSERTION IN THE LEFT HIP. RESPONSE: THE REPORT WAS RECEIVED BY THE IMPORTER ON (B)(6) 17. THE INITIAL REPORTER WAS CONTACTED VIA PHONE ON THE SAME DATE, AND A REQUEST WAS MADE TO FORWARD PICTURES OF THE DEVICE BECAUSE BASED ON THE DESCRIPTION IN THE REPORT, IT WAS NOT UNDERSTOOD HOW THE DEVICE WAS DETERMINED TO BE AN INNOMED PART. PICTURES OF THE DEVICE WAS RECEIVED AT INNOMED ON (B)(6) 2017, AND AFTER REVIEW, IT WAS VERIFIED AS AN INNOMED PART. THE IMPORTER ALSO REQUESTED MORE INFORMATION VIA EMAIL REGARDING THE SERIES OF EVENTS THAT LED TO THE BREAK AS THE ABOVE DESCRIPTION IS NOT SUFFICIENT ENOUGH TO PERFORM A THOROUGH INVESTIGATION. A FOLLOW UP EMAIL WAS SENT ON (B)(6) 2017 REQUESTING THE SAME INFORMATION. NO RESPONSE WAS RECEIVED FROM THE INITIAL REPORTER. WHEN THE REQUESTED INFORMATION IS PROVIDED, AN INVESTIGATION WILL ENSUE, AND AN UPDATE WILL BE FORWARDED TO THE CDRH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564387 INTERCHANGEABLE HEAD-50 MM- DELRIN EXTRACTOR HWB INNOMED, INC. 5202-50 0114I 00840277104496

    Patients

    Seq Age Sex Outcome Treatment
    1