BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRH TIBIAL B/PLT KEEL SML 1

    MDR report key: 1942442 · Received December 22, 2010

    Report

    Report Number
    9610726-2010-00490
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 26, 2010
    Report Date
    December 13, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    KRO
    PMA / PMN Number
    K994207
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER FORWARDED TO (B)(6) THIS REPORT: A PT UNDERWENT A SURGICAL PROCEDURE IN 2005 OF KNEE REPLACEMENT. AFTER 2 YRS, THE PT EXPERIENCED A DISLOCATION OF THE FEMORAL COMPONENT AND HE/SHE UNDERWENT AND UNANTICIPATED REVISION SURGERY ON (B)(6) 2007. ON (B)(6) 2010, THE PT UNDERWENT ANOTHER SURGICAL PROCEDURE DUE TO THE LOOSENING OF THE PROSTHESIS IMPLANTED IN 2007. THE RA/QA SPECIALIST CONTACTED THE CUSTOMER IN ORDER TO COLLECT ALL THE MISSING INFO (PRODUCT CODES AND SERIAL NUMBERS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRH TIBIAL B/PLT KEEL SML 1 IMPLANT KRO STRYKER ORTHOPAEDICS LIMERICK NA TRN091J1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention