BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA V-40 CERAMIC HEAD 28/+4

    MDR report key: 7536699 · Received May 23, 2018

    Report

    Report Number
    0002249697-2018-01542
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    January 19, 2018
    Report Date
    May 23, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K173499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. 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.

    Description of Event or Problem · 1

    AS REPORTED: "THIS PATIENT WAS PARTICIPATING IN STRYKER'S RESTORATION ADM X3 STUDY. AS PER THE ADVERSE EVENT FORM, THE "PATIENT REPORTS PAIN IN OUTER ASPECT OF HIP. PHYSICIAN NOTES TROCHANTERIC TENDERNESS AND NO NEUROVASCULAR DEFICIT." THE HIP WAS ASPIRATED AND THERE WAS FOUND TO BE A RIGHT HIP INFECTION. AS PER THE OPERATIVE NOTES, THE PATIENT WAS REVISED DUE TO A "FAILED HIP REPLACEMENT SECONDARY TO IMPINGEMENT AND SEVERE METALLOSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378498 DELTA V-40 CERAMIC HEAD 28/+4 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH 44475502

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R