BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM CEMENTLESS ACETABULAR SHELL

    MDR report key: 3183961 · Received June 12, 2013

    Report

    Report Number
    3005180920-2013-00067
    Event Type
    Injury
    Date Received
    June 12, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K083116
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP DOUBLE MOBILITY ACETABULAR SHELL - REF. 01.26.52MB / LOT 101398 ((B)(4) SHELLS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDED WASHING AND STERILIZATION CYCLES. ALL THE CUPS BELONGING TO THIS LOT HAVE ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. AMISTEM H FEMORAL STEM CEMENTLESS (K093944) - REF. 01.18.142 / LOT 101852 ((B)(4) STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION CYCLES. (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. FROM THE DATA COLLECTED, DURING THE FIRST REVISION, THERE WAS A WRONG COUPLING BETWEEN THE NEW DM LINER IMPLANTED (CODE 01.26.2850MHC / LOT 110320 / SIZE 50) AND THE VERSAFITCUP DM CUP KEPT IN PLACE (SIZE 52), EVEN IF THE RIGHT COUPLING IS CLEARLY INDICATED ON THE PRODUCT LABELING; IT IS POSSIBLE THAT THIS MISMATCH CREATED WEAR DEBRIS THAT CONTRIBUTED TO THE LOOSENING OF THE CEMENTLESS COMPONENTS (CUP AND STEM). THE EVENT SEEMS TO BE HIGHLY LIKELY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267504 VERSAFITCUP DM CEMENTLESS ACETABULAR SHELL ACETABULAR DOUBLE MOBILITY SHELL LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1