BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP SPACER MOLD 9 X125 X 43MM

    MDR report key: 3211832 · Received July 8, 2013

    Report

    Report Number
    0001825034-2013-02542
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK052990
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. A REVIEW OF SALES AND COMPLAINT HISTORY FOR THIS ITEM AND LOT FOUND 25 ITEMS INVOICED WITH NO OTHER COMPLAINTS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT STAGE ONE REVISION ON (B)(6) 2013. IT WAS FOUND THE HIP SPACER MOLD WAS NOT IN THE PACKAGE. AS A RESULT A 45 MINUTE DELAY OCCURED. IT IS UNKNOWN WHAT PRODUCT WAS BEING EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309079 HIP SPACER MOLD 9 X125 X 43MM PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 036300

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization