BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3925576 · Received July 10, 2014

    Report

    Report Number
    0002249697-2014-02601
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN FEMORAL COMPONENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. HOSPITAL RETAINS EXPLANTS.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING LOOSE FEMUR INVOLVING AN UNKNOWN FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE PROVIDED PATIENT GENERAL HISTORY AND PRE-OP EVALUATION WERE SUBMITTED TO A CONSULTING CLINICIAN WHO DEEMED IT INSUFFICIENT FOR A MEDICAL REVIEW. THE REPORTED EVENT COULD NOT BE CONFIRMED WITH THE PROVIDED INFORMATION. NEED OPERATIVE REPORTS AND X-RAYS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT MEDICAL RECORDS WERE PROVIDED FOR EVALUATION. NO X-RAYS OR DEVICE WERE PROVIDED FOR EVALUATION WHICH IS NEEDED TO DETERMINE THE ROOT CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT KNEE DONE IN 2013, THE PATIENT HAD SWELLING, PAIN, BRUISING AND BLOOD TESTS DONE TO SEE REASON FOR PAIN. SURGEON DECIDED TO REVISE, DURING SURGERY SURGEON NOTED THAT THE FEMUR APPEARED LOOSE. SURGEON REVISED AND CEMENTED IN THE FEMUR AND LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT KNEE DONE IN 2013, THE PATIENT HAD SWELLING, PAIN, BRUISING AND BLOOD TESTS DONE TO SEE REASON FOR PAIN. SURGEON DECIDED TO REVISE, DURING SURGERY SURGEON NOTED THAT THE FEMUR APPEARED LOOSE. SURGEON REVISED AND CEMENTED IN THE FEMUR AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404023 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention