BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON CR FEM COMP #8 L-CEM

    MDR report key: 2950930 · Received February 8, 2013

    Report

    Report Number
    0002249697-2013-00600
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K926228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 INVESTIGATION FOR SIMILAR EVENT CONCLUDED THAT THE PACKAGING DAMAGE WAS CAUSED BY EXCESSIVE HANDLING DURING DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER PLASTIC PACKAGING WAS DAMAGED. SALES REP HAD A SPARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER PLASTIC PACKAGING WAS DAMAGED. SALES REP HAD A SPARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54678 TRIATHLON CR FEM COMP #8 L-CEM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other