BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RACER KNEE

    MDR report key: 18255338 · Received December 4, 2023

    Report

    Report Number
    0002249697-2023-01477
    Event Type
    Injury
    Date Received
    December 4, 2023
    Date of Event
    July 18, 2023
    Report Date
    December 4, 2023
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED: RACER RELATED EVENT (ANONYMIZED TRIAL) - NO OTHER INFORMATION AVAILABLE: "SUPERFICIAL WOUND INFECTION ON TIBIAL PIN SITES, DISCHARGING PUS. 1G OF FLUCLOXACILLIN PRESCRIBED QDS FOR SEVEN DAYS AND BLOOD TEST. PATIENT SEEN BACK IN CLINIC ON (B)(6) 2023, WOUND INFECTION RESOLVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451680 UNKNOWN_RACER KNEE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other