BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3003461 · Received March 14, 2013

    Report

    Report Number
    0002249697-2013-00988
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    July 1, 1999
    Report Date
    February 22, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT NO FURTHER INFORMATION IS AVAILABLE AS THE HOSPITAL WHERE THE PRIMARY SURGERY OCCURRED IS UNKNOWN. THIS EVENT WAS DISCOVERED DURING A MEDICAL RECORD REVIEW AND THE DEVICE WAS REPORTED AS AN UNKNOWN LINER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION INVOLVING AN UNKNOWN LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED. THE PROVIDED MEDICAL RECORDS WERE REJECTED FOR CLINICIAN REVIEW AS THEY WERE DETERMINED AS INSUFFICIENT TO PROVIDE MEANINGFUL INSIGHT INTO THE REPORTED EVENT. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE REPORTED DEVICE LOT CODE WAS NOT PROVIDED. A REVIEW OF THE COMPLAINT DATABASES COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NOT PROPERLY IDENTIFIED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS FOUND VIA PATIENT'S MEDICAL RECORDS THAT PATIENT DISLOCATED TWICE OVER THE FIRST YEAR AND A HALF. NO SPECIFIC MEDICAL INTERVENTION WAS NOTED IN THE RECORDS.

    Description of Event or Problem · 1

    IT WAS FOUND VIA PATIENT'S MEDICAL RECORDS THAT PATIENT DISLOCATED TWICE OVER THE FIRST YEAR AND A HALF. NO SPECIFIC MEDICAL INTERVENTION WAS NOTED IN THE RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107897 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other