BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE 3 ACCOLADE II 127 DEG

    MDR report key: 10777707 · Received November 3, 2020

    Report

    Report Number
    0002249697-2020-02301
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    October 8, 2020
    Report Date
    November 3, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    04546540669483
    PMA / PMN Number
    K143085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    DR. REVISED A FEMORAL HEAD DUE TO A FEMORAL FRACTURE WHICH REQUIRED CABLING FOR A LEFT HIP. UPDATE 09/OCTOBER/2020: 36 +0 CERAMIC HEAD WAS REVISED TO A 36MM CERAMIC HEAD WITH +0 SLEEVE AND TWO CABLE AND SLEEVE SETS. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244902 SIZE 3 ACCOLADE II 127 DEG PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 6721-0330 78469903 04546540669483

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R