BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMRS DIST FEM COMP STD R 65MM

    MDR report key: 3071400 · Received April 22, 2013

    Report

    Report Number
    0002249697-2013-01359
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K023087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE VISUAL INSPECTION OF THE RETURNED PACKAGING APPEARS THAT THIS COMPONENT PACKAGING WAS SUBJECTED TO EXCESSIVE HANDLING WHEREBY THE UNIT CARTON WAS COMPRESSED TO THE EXTENT THAT THE OUTER BLISTER CRACKED UNDER THE COMPRESSIVE FORCE IT WAS SUBJECTED TO. DHR REVIEW FOR THE REPORTED LOT DETERMINED THAT THE DEVICE WAS MANUFACTURED AND PACKED TO SPECIFICATION. CHR REVIEW DETERMINED THAT THERE WERE NO SIMILAR EVENTS REPORTED FOR THE LOT. THIS INVESTIGATION IS SIMILAR TO EVENT WHEREBY THE INVESTIGATION FOR A SIMILAR EVENT FOR THE SAME PACK CONFIGURATION CONCLUDED THAT THE PACKAGING DAMAGE WAS CAUSED BY EXCESSIVE HANDLING DURING DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGICAL PROCEDURE OF A REVISION OF A RIGHT GMRS DISTAL FEMUR. THE SURGEON DID A TRIAL REDUCTION AND REQUESTED THAT THE STD RIGHT GMRS DISTAL FEMUR COMPONENT (6495-2-040) BE OPENED. THE CIRCULATING NURSE NOTICED THAT THE PLASTIC BOARDER ON THE INNER PACKAGING WAS CRACKED AND THE IMPLANT STERILITY AS POTENTIALLY CONTAMINATED. WE OPENED AND USED A SMALL RIGHT GMRS DISTAL FEMUR (6495-2-020). THIS COMPONENT WAS IMPLANTED AND SURGEON WAS SATISFIED WITH THE POST OP RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGICAL PROCEDURE OF A REVISION OF A RIGHT GMRS DISTAL FEMUR. THE SURGEON DID A TRIAL REDUCTION AND REQUESTED THAT THE STD RIGHT GMRS DISTAL FEMUR COMPONENT (6495-2-040) BE OPENED. THE CIRCULATING NURSE NOTICED THAT THE PLASTIC BOARDER ON THE INNER PACKAGING WAS CRACKED AND THE IMPLANT STERILITY AS POTENTIALLY CONTAMINATED. WE OPENED AND USED A SMALL RIGHT GMRS DISTAL FEMUR (6495-2-020). THIS COMPONENT WAS IMPLANTED AND SURGEON WAS SATISFIED WITH THE POST OP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173070 GMRS DIST FEM COMP STD R 65MM IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH S9MKA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other