BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SIMPLEX HV WITH ANTIBIOTICS

    MDR report key: 10513434 · Received September 10, 2020

    Report

    Report Number
    0002249697-2020-01836
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    July 13, 2019
    Report Date
    September 10, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED.

    Description of Event or Problem · 1

    THIS PI IS FOR SIMPLEX HV WITH ANTIBIOTICS. IN THE JOURNAL OF ARTHROPLASTY ARTICLE "PRIMARY TOTAL KNEE ARTHROPLASTY PERFORMED USING HIGH-VISCOSITY CEMENT IS ASSOCIATED WITH HIGHER ODDS OF REVISION FOR ASEPTIC LOOSENING," ONE TABLE PROVIDES INFORMATION THAT FOR SIMPLEX HV, WITH AND WITHOUT ANTIBIOTICS, 20 REVISIONS WERE PERFORMED FOR ASEPTIC LOOSENING. STUDY COHORT (1072 PATIENTS TOTAL, INCLUDING PATIENTS WITH COMPETITOR CEMENT) HAD A MEAN AGE OF 64.9 ±8.9 YEARS. 39.3% OF PATIENTS WERE MALE, 60.7% FEMALE. JOURNAL OF ARTHROPLASTY 35 (220) S182-S189.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981157 UNKNOWN SIMPLEX HV WITH ANTIBIOTICS BONE CEMENT, ANTIBIOTIC MBB STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R