BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3924313 · Received July 9, 2014

    Report

    Report Number
    0002249697-2014-02587
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K070095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY RECORDS COULD NOT BE PERFORMED BECAUSE THE DEVICE ASSOCIATED WITH THIS EVENT WAS NOT RETURNED NOR WAS A VALID LOT CODE PROVIDED. THE REVISION OPERATIVE REPORT WAS PROVIDED. CLINICAL HISTORY, OFFICE NOTES, AND X-RAYS WERE NOT PROVIDED. INSUFFICIENT INFORMATION WAS RECEIVED FOR A MEDICAL REVIEW. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION BECAUSE IT WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    HCA EMPLOYEE IS INQUIRING IF A PATIENT'S PRIMARY KNEE COMPONENTS FROM A PREVIOUS SURGERY ARE REIMBURSABLE/DISCOUNTABLE THROUGH STRYKER BECAUSE THE COMPONENTS WERE LOOSE (ACCORDING TO SURGEON'S REVISION POST-OP NOTES) AND REQUIRED REVISION KNEE SURGERY.

    Description of Event or Problem · 1

    (B)(6) IS INQUIRING IF A PATIENT'S PRIMARY KNEE COMPONENTS FROM A PREVIOUS SURGERY ARE REIMBURSABLE/DISCOUNTABLE THROUGH STRYKER BECAUSE THE COMPONENTS WERE LOOSE (ACCORDING TO SURGEON'S REVISION POST-OP NOTES) AND REQUIRED REVISION KNEE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399747 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention