BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRITANIUM REVISION ACETABULAR

    MDR report key: 7307252 · Received March 1, 2018

    Report

    Report Number
    0002249697-2018-00594
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    February 1, 2018
    Report Date
    March 1, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327025156
    PMA / PMN Number
    K143085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: TRIDENT X3 ECCENTRIC 10° 36MM ID; 663-10-36E; 5X5RPX. TI SLEEVE FOR ALUMINA HEAD; 17-0000E; 83377N. DELTA C-TAPER HEAD 36MM +5; 18-3605; 55446202. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO FAILED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151692 TRITANIUM REVISION ACETABULAR PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH XA1JR3 07613327025156

    Patients

    Seq Age Sex Outcome Treatment
    1 63 MO Hospitalization| R