BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEADS 12/14 32 SIZE S

    MDR report key: 2858829 · Received November 9, 2012

    Report

    Report Number
    3005180920-2012-00070
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW ON THE LOTS OF IMPLANTS EXPLANTED: COCR BALL HEAD 12/14 32 SIZE MM: (B)(4)/LOT 122449 ((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. NINE ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. VERSAFITCUP CC LINER 32/E: (B)(4)/LOT 122078 ((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. FORTY-THREE LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. THE SAME CONTROL WAS PERFORMED ON THE LOTS OF IMPLANTS NOT EXPLANTED (FEMORAL STEM AND METAL BACK): AMISTEM H FEMORAL STEM (K093944) (B)(4)/LOT 121497. BATCH REVIEW OK: NO ANOMALIES FOUND. TEN STEMS ALREADY IMPLANTED OF THE (B)(4) PRODUCED, WITHOUT ANY SIMILAR INCIDENT. VERSAFITCUP CC TRIO CUP (K103352) (B)(4)/LOT 1222518. BATCH REVIEW OK: NO ANOMALIES FOUND. FORTY-TWO CUPS ALREADY IMPLANTED OF THE (B)(4) PRODUCED, WITHOUT ANY SIMILAR INCIDENT. ON THE BASIS OF THE DATA COLLECTED, A DEVICE INVOLVEMENT IN THE INFECTION IS HIGHLY UNLIKELY.

    Description of Event or Problem · 1

    REVISION SURGERY 1 MONTH POST OP DUE TO SUSPECTED INFECTION. THE BALL HEAD AND THE INSERT WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COCR BALL HEADS 12/14 32 SIZE S FEMORAL BALL HEADS JDI MEDACTA INTERNATIONAL, SA 122449

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LOT 122078, 510 (K) NUMBER: K103352| VERSAFITCUP CC LINER: (B)(4)