BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM ACETABULAR CUP 56

    MDR report key: 4391447 · Received December 29, 2014

    Report

    Report Number
    3005180920-2014-00195
    Event Type
    Injury
    Date Received
    December 29, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VERSAFITCUP DM ACETABULAR SHELL 56, CODE 01.26.56MB - LOT 144751 ((B)(4) SHELLS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. SOME (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. VERSAFITCUP DM ACETABULAR LINER 56, CODE 01.26.2856MHC - LOT 144791 ((B)(4) LINERS PRODUCED - K092265): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. SOME (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. MECTACER BIOLOX DELTA BALL HEAD 28 L, CODE 01.29.2203 - LOT 134585 ((B)(4) HEADS PRODUCED - K112115): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. SOME (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. AMISTEM H COLLARED CEMENTLESS STEM SIZE 6 STD, CODE 01.18.236 - LOT 144103 ((B)(4) STEMS PRODUCED - K121011): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. SOME (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. ON THE BASIS OF THE DATE COLLECTED, WE HAVE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMP REPORT #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854755 VERSAFITCUP DM ACETABULAR CUP 56 DOUBLE MOBILITY ACETABULAR SHELL MEH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1