BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT MAX 132 HIP STEM #10

    MDR report key: 10552389 · Received September 18, 2020

    Report

    Report Number
    0002249697-2020-01928
    Event Type
    Injury
    Date Received
    September 18, 2020
    Date of Event
    August 25, 2020
    Report Date
    September 18, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    UDI-DI
    07613327021042
    PMA / PMN Number
    K051738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICE WAS ALSO LISTED IN THIS REPORT: DEVICE NAME; DELTA C-TAPER HEAD 36MM +5; CAT #: 18-3605; LOT #: 69898402. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. POSSIBLE CAUSE OR CONTRIBUTOR FOR PAIN NOT REPORTED. THE PATIENT'S STEM AND HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT AND ANOTHER HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019628 SECUR-FIT MAX 132 HIP STEM #10 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO STRYKER ORTHOPAEDICS-MAHWAH 6051-1035S 8Y7E13 07613327021042

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R