BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KX+ DURAT INSERT MED 12MM

    MDR report key: 2986804 · Received March 4, 2013

    Report

    Report Number
    0002249697-2013-00841
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K872735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT E PERFORMED AS THE PROVIDED LOT NUMBER WAS INVALID. THE PROVIDED MEDICAL INFORMATION WAS SUBMITTED TO A CONSULTING CLINICIAN WHO DEEMED IT INSUFFICIENT FOR A MEDICAL REVIEW. THE EVENT COULD NOT BE CONFIRMED. BASED ON THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION CONCLUDED THAT THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS MANUFACTURING RELATED. IT IS NOTED THAT WHEN THE DOUBLE BARRIER PACKAGING IS OPENED, THE STERILITY OF ANY DEVICE BECOMES A FUNCTION OF HANDLING AND SURGICAL TECHNIQUE AND IS BEYOND STRYKER'S CONTROL. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF THE DEVICE AND/OR ADDITIONAL INFORMATION SUCH AS OPERATIVE NOTES, PATHOLOGY REPORTS AND ADDITIONAL X-RAYS BECOMES AVAILABLE, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. OTHER DEVICES LISTED IN THIS REPORT: UNKNOWN TIBIAL BASEPLATE. UNKNOWN MEDIUM PATELLA. UNKNOWN FEMUR. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT HAS AN INFECTED TKA AND THE SURGEON REMOVED THE COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. PATIENT PRESENTED IN CLINIC, 1ST REVISION WAS 2003, POLY EXCHANGE AND PATELLA REVISION WAS COMPLETED AT THAT TIME.

    Description of Event or Problem · 1

    PATIENT HAS AN INFECTED TKA AND THE SURGEON REMOVED THE COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. PATIENT PRESENTED IN CLINIC, 1ST REVISION WAS 2003, POLY EXCHANGE AND PATELLA REVISION WAS COMPLETED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91760 KX+ DURAT INSERT MED 12MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH CP88174

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention