BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21MM MOD REV HIP BDY/BLT + 10MM COMPONENT LEVEL 9006

    MDR report key: 1760188 · Received July 12, 2010

    Report

    Report Number
    9616680-2010-00447
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K013106
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR #9616680-2010-00446.

    Description of Event or Problem · 1

    IT WAS REPORTED, "PROXIMAL CONE BODY WAS FULLY SEATED ON CONICAL STEM. THE SCREW WAS TIGHTENED WITH THE 5MM SCREWDRIVER AND THEN TORQUED AS PER SURGICAL TECHNIQUE. AT 120PSI THE 1ST SCREW CUT OUT AND WHEN REMOVED, YOU COULD SEE THE CROSS THREADING. A SECOND PROSTHESIS WAS OPENED AND THE SCREW USED WITH EXACTLY THE SAME OUTCOME. A THIRD PROX BODY WAS OPENED AND THE SCREW WAS HAND TIGHTENED AS MUCH AS POSSIBLE AND TORQUED TO 80PSI AND THE SURGEON CHOSE TO LEAVE IT AT THAT PRESSURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 21MM MOD REV HIP BDY/BLT + 10MM COMPONENT LEVEL 9006 IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 27180601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other