BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP CC PE LINER O 32 E

    MDR report key: 3721185 · Received March 14, 2014

    Report

    Report Number
    3005180920-2014-00028
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFIT CUP CC LINER - REF. 01.26.3244HCT/LOT 133462 ((B)(4) LINERS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. (B)(4) LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO OTHER INCIDENTS HAVE BEEN REPORTED UP TO NOW. VERSAFITCUP CC TRIO NO HOLE CUP O 50 - REF. 01.26.45.1150 / LOT 134939 ((B)(4) CUPS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. (B)(4) CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO OTHER INCIDENTS HAVE BEEN REPORTED UP TO NOW. THE EVENT IS HIGHLY LIKELY NOT DEVICE RELATED, BUT MOST PROBABLY DUE TO AN INCORRECT IMPACTION OF THE LINER INTO THE SHELL.

    Description of Event or Problem · 1

    REFERENCE IMPORTER # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152173 VERSAFITCUP CC PE LINER O 32 E ACETABULAR PE LINER LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1