BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALL POLY CONSTRAINED INSERT 54MM

    MDR report key: 2032254 · Received March 17, 2011

    Report

    Report Number
    2249697-2011-00329
    Event Type
    Death
    Date Received
    March 17, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 23, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    K061654
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PER RAISED WITH LIMITED INFORMATION!! (B)(6) REPORTED VIA OUR SALES REP THAT PT CAME TO THE HOSP WITH DISLOCATED HIP. SENIOR SURGEON DR. (B)(6) CONTACTED SALES REP ON (B)(6) 2011 TO ASK FOR THE REGISTRATIONS OF THE IMPLANT PASS WHICH GAVE NO USEFUL RESULT. THERE WERE ALSO IMPLANTS OF THE FIRST SURGERY MENTIONED. FURTHER THEY REPORTED THAT DURING SURGERY, THEY DETERMINED THAT THE BIPOLAR HIP WAS DAMAGED AND THUS EMERGED THE LUXATION. SURGERY WAS DELAYED BY 30 MINUTES AND THAT DESIRED RESULT WAS ACHIEVED. X-RAYS AND SURGERY REPORT WILL BE PROVIDED. SURGEONS HAVE NOT INDICATED THE CAUSE OF DEATH WAS IN THEIR OPINION PRODUCT RELATED, PT RELATED OR A COMBINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALL POLY CONSTRAINED INSERT 54MM IMPLANT KWZ STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Death