BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI SOLIDBACK CUP 54MM

    MDR report key: 3935782 · Received July 15, 2014

    Report

    Report Number
    0002249697-2014-02710
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED. VISUAL INSPECTION; THE DEVICE WAS RETURNED WITH NORMAL SIGNS OF EXPLANTATION INCLUDING SOME BONY INGROWTH. DIMENSIONAL INSPECTION: NOT PERFORMED AS THE DEVICE WAS RETURNED IN USED CONDITION AND WILL NOT MEET DIMENSIONAL SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY LOOSE ACETABULAR COMPONENT WAS FOUND. IT WAS PATIENT'S RIGHT SIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY LOOSE ACETABULAR COMPONENT WAS FOUND. IT WAS PATIENT'S RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412088 PRIMARY TRITANIUM HEMI SOLIDBACK CUP 54MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH METHNH

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention