BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEADS 12/14 28 SIZE L

    MDR report key: 3435492 · Received October 18, 2013

    Report

    Report Number
    3005180920-2013-00126
    Event Type
    Injury
    Date Received
    October 18, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MBH
    PMA / PMN Number
    K072857
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: COCR BALL HEAD 12/14 28 SIZE L: CODE (B)(4) / LOT 111574 ((B)(4) HEADS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION CYCLES. THE (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. VERSAFITCUP DOUBLE MOBILITY ACETABULAR LINER (K092265): CODE (B)(4) / LOT 111961 ((B)(4)LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION CYCLES. ALL THE ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. ON THE BASIS OF THE DATA COLLECTED, A DEVICE INVOLVEMENT IN THE DISLOCATION IS HIGHLY UNLIKELY.

    Description of Event or Problem · 1

    REFERENCE # 3006639916-2013-00126.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535225 COCR BALL HEADS 12/14 28 SIZE L FEMORAL BALL HEADS MBH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1