BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UHR BIPOLAR 26X45MM

    MDR report key: 18323911 · Received December 14, 2023

    Report

    Report Number
    0002249697-2023-01561
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    November 28, 2023
    Report Date
    December 14, 2023
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWL
    UDI-DI
    07613327016925
    PMA / PMN Number
    K800207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: C-TAPER COCR LFIT HEAD 26MM/+10; CAT # 06-2610; LOT # 4M41MW OMNIFIT CEMENTED LONG STEM NO 5 300L; CAT # 6088-0525-300L; LOT # NJ7H84 IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. A BIPOLAR COMPONENT AND FEMORAL HEAD WERE REVISED TO ANOTHER BIPOLAR COMPONENT AND FEMORAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272412 UHR BIPOLAR 26X45MM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL KWL STRYKER ORTHOPAEDICS-MAHWAH 8L0TDV 07613327016925

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention| H