BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28X52-55MM NEUTRAL INS

    MDR report key: 2010695 · Received February 25, 2011

    Report

    Report Number
    2249697-2011-00221
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 2, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDL
    PMA / PMN Number
    K921384
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT: A PT UNDER WENT A SURGICAL PROCEDURE OF TOTAL HIP REPLACEMENT DUE TO COXARTHRITIS. ON (B)(6) 2011, THE PT UNDERWENT AN UNANTICIPATED REVISION SURGERY DUE TO THE WEAR OF POLYETHYLENE INSERT IMPLANTED. THE OPINION OF THE SURGEON IS THAT THE WEAR OF THE POLYETHYLENE INSERT IS CERTAINLY DUE TO THE NORMAL WEAR AND NOT RELATED TO THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 28X52-55MM NEUTRAL INS IMPLANT JDL STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R