BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP STEM

    MDR report key: 2915537 · Received January 10, 2013

    Report

    Report Number
    2249697-2013-90100
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 27, 2011
    Report Date
    December 20, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. THE REASON FOR THE STERILIZATION STARTING WITH (B)(4) IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED "THROUGH THE FILING OF A LAWSUIT THAT THE PATIENT EXPERIENCING SIGNIFICANT PAIN AND DISCOMFORT IN THE AREA OF THE DEVICE. IT IS FURTHER ALLEGED ALTHOUGH X-RAYS AND A CT SCAN FROM (B)(6) 2012, SHOWED A WELL POSITIONED AND ALIGNED RIGHT TOTAL HIP ARTHROPLASTY WITHOUT ANY EVIDENCE OF LOOSENING, WEAR, FRACTURE, THE PATIENT CONTINUED TO EXPERIENCE SIGNIFICANT PAIN. IT IS FURTHER ALLEGED THAT IN, LIGHT OF WORSENING SYMPTOMS, THE PATIENT UNDERWENT SURGERY ON (B)(6) 2012."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14968 UNKNOWN HIP STEM IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention