BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19MM MOD REV HIP BDY/BLT +20MMCOMPONENT LEVEL 9006

    MDR report key: 1960182 · Received December 21, 2010

    Report

    Report Number
    9616680-2010-00837
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR.# 9616680-2010-00838.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "IN THE PROCESS OF OPENING PROX CONE BODY (B)(4), SURG. TECH DISPOSED OF LOCKING BOLT. A NEW BODY WAS OPENED FOR THE BOLT. WHEN ATTEMPTING TO TIGHTEN, I INFORMED THE SURGEON THAT BOLT WOULD BE TOO LONG. HEAD OF BOLT HAD BEEN SEATED TO LEVEL OF CONE BODY. SURGEON WAS THEN INFORMED BOLT SHOULD BE PROUD IF TOO LONG AND THAT BODY MAY NOT BE FULLY SEATED. BOLT ATTEMPTED TO BE REMOVED, BUT IT SPUN WITHOUT TIGHTENING OR BACKING OUT. I AGAIN INFORMED SURGEON THAT BOLT WAS NOT APPROPRIATE LENGTH AND SHOULD BE REMOVED. REMOVAL WAS ATTEMPTED, BUT SURGEON FELT PROSTHESIS WAS WELL FIXED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 19MM MOD REV HIP BDY/BLT +20MMCOMPONENT LEVEL 9006 IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 32986201

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other