BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEADS 12/14 36 SIZE L

    MDR report key: 2999493 · Received March 5, 2013

    Report

    Report Number
    3005180920-2013-00005
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: COCR BALL HEAD 12/14 36 SIZE L: CODE 01.25.032 / LOT 121068 (20 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 3 ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. AMISTEM H FEMORAL STEM (K093944): CODE 01.18.139 / LOT 104260 (18 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION CYCLES. THE 5 STEMS 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 INFECTION IS HIGHLY UNLIKELY.

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: COCR BALL HEAD 12/14 36 SIZE L: CODE 01.25.032 / LOT 121068 (20 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 3 ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. AMISTEM H FEMORAL STEM (K093944): CODE 01.18.139 / LOT 104260 (18 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION CYCLES. THE 5 STEMS 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 INFECTION IS HIGHLY UNLIKELY.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION 20 DAYS POST OP. THE BACTERIA RESPONSIBLE FOR THE INFECTION IS A (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93115 COCR BALL HEADS 12/14 36 SIZE L FEMORAL BALL HEADS LZO MEDACTA INTERNATIONAL SA 121068

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LOT 104260 (K093944)| AMISTEM H FEMORAL STEM: CODE 01.18.139