BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/H RADIAL SOLID/APX SHL 46MM

    MDR report key: 3013465 · Received March 20, 2013

    Report

    Report Number
    0001825034-2013-00672
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK921181
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE EXPLANTED DEVICE WAS NOT POSSIBLE DUE TO THE CUP COULD NOT BE REMOVED FROM THE INSERTER. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00671-1 / 00672-1).

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00671 / 00372).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. DURING THE PROCEDURE AFTER THE CUP IMPACTION, THE CUP WOULD NOT DISENGAGE FROM THE INSERTER HANDLE. THE SURGEON USED A RATCHET DRIVER TO TRY TO DISENGAGE THE CUP TWICE. THE TIP OF THE DRIVER FRACTURED BUT DID NOT FALL INTO PATIENT'S WOUND. AS A RESULT, THE SURGEON USED A DIFFERENT CUP AND A STRAIGHT INSERTER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115198 M/H RADIAL SOLID/APX SHL 46MM PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 729660

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R