BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX HV US 1 PACK

    MDR report key: 6487994 · Received April 12, 2017

    Report

    Report Number
    0002249697-2017-01239
    Event Type
    Injury
    Date Received
    April 12, 2017
    Date of Event
    March 13, 2017
    Report Date
    June 8, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K123225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING SIMPLEX HV CEMENT WAS REPORTED. THE EVENT RELATES TO PRODUCT SUPPLIED BY AN OEM. (B)(4) IS A DISTRIBUTOR OF THIS DEVICE, WHICH IS MANUFACTURED BY AAP. THE MANUFACTURER IS RESPONSIBLE FOR REGULATORY DECISIONS UNDER MDR/MDV AND SUBMITTING ANY REQUIRED MDR/MDV REPORTS. SUPPLIER HAS BEEN NOTIFIED. SERIOUS INJURY REPORTS FOR HV PRODUCTS ARE ALSO FILED TO THE FDA VIA (B)(4) HOWEVER THE INVESTIGATION AND RESULTS ARE PROCESSED BY AAP.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    RIGHT KNEE REVISED DUE TO LOOSE FEMORAL COMPONENT. LITTLE TO NO CEMENT ADHERED TO FEMORAL COMPONENT. REASON FOR THE SURGERY WAS KNEE PAIN. THE ONLY STRYKER PRODUCT USED WAS THE SIMPLEX HV CEMENT.

    Description of Event or Problem · 1

    RIGHT KNEE REVISED DUE TO LOOSE FEMORAL COMPONENT. LITTLE TO NO CEMENT ADHERED TO FEMORAL COMPONENT. REASON FOR THE SURGERY WAS KNEE PAIN. THE ONLY STRYKER PRODUCT USED WAS THE SIMPLEX HV CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270209 SIMPLEX HV US 1 PACK BONE CEMENT LOD STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R