BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL FEM COMP STD

    MDR report key: 5167521 · Received October 22, 2015

    Report

    Report Number
    0002249697-2015-03434
    Event Type
    Malfunction
    Date Received
    October 22, 2015
    Date of Event
    September 24, 2015
    Report Date
    September 24, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K023087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING A GMRS PROXIMAL FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: BASED ON THE VISUAL INSPECTION OF THE RETURNED PACKAGING IT APPEARS THAT THIS COMPONENT PACKAGING WAS SUBJECTED TO EXCESSIVE/INAPPROPRIATE HANDLING WHEREBY THE CARTON MAY HAVE BEEN COMPRESSED AND/OR DROPPED FROM A HEIGHT CAUSING THE FLANGE OF THE OUTER BLISTER TO FRACTURE. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS THE EVENT IS RELATED TO A PACKAGING ISSUE AND NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. -DEVICE HISTORY REVIEW: DHR REVIEW FOR THE REPORTED LOT DETERMINED THAT THE DEVICE WAS MANUFACTURED AND PACKED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE PACKAGING DAMAGE WAS MOST LIKELY CAUSED BY EXCESSIVE/INCORRECT HANDLING DURING TRANSPORTATION/STORAGE. NO FURTHER INVESTIGATION FOR THIS EVENT IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    UPON SELECTION OF IMPLANT THE BOX WAS IN GREAT SHAPE. WHEN THE NURSE OPENED THE BOX THE INSIDE PACKAGING WAS CRACKED BUT THE INNER PACKAGING WAS STILL IN TACT. SURGEON WANTED A DIFFERENT IMPLANT DUE TO STERILITY SO WE OPENED ANOTHER IMPLANT. THE BOX WAS IN GOOD SHAPE, BUT THE PLASTIC PACKAGING WAS CRACKED AND SO WAS THE INNER PACKAGE. IT LOOKS LIKE SOMEONE CRACKED THE PLASTIC CARTONS BEFORE PUTTING INTO STRYKER BOX.

    Description of Event or Problem · 1

    UPON SELECTION OF IMPLANT THE BOX WAS IN GREAT SHAPE. WHEN THE NURSE OPENED THE BOX THE INSIDE PACKAGING WAS CRACKED BUT THE INNER PACKAGING WAS STILL IN TACT. SURGEON WANTED A DIFFERENT IMPLANT DUE TO STERILITY SO WE OPENED ANOTHER IMPLANT. THE BOX WAS IN GOOD SHAPE, BUT THE PLASTIC PACKAGING WAS CRACKED AND SO WAS THE INNER PACKAGE. IT LOOKS LIKE SOMEONE CRACKED THE PLASTIC CARTONS BEFORE PUTTING INTO STRYKER BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699035 PROXIMAL FEM COMP STD PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH EJFHD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other