BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRITANIUM REVISION ACETABULAR

    MDR report key: 3844244 · Received June 2, 2014

    Report

    Report Number
    0002249697-2014-02025
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K010170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING A TRITANIUM SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY REVIEW INDICATED THAT THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS FURTHER INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENTS RIGHT HIP WAS BEING REVISED DUE TO ACETABULAR LOOSENING. THE SURGEON STATED THAT HE SAW NO BONE INGROWTH ON THE IMPLANT.

    Description of Event or Problem · 1

    THE PATIENTS RIGHT HIP WAS BEING REVISED DUE TO ACETABULAR LOOSENING. THE SURGEON STATED THAT HE SAW NO BONE INGROWTH ON THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322288 TRITANIUM REVISION ACETABULAR IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH A3JMJE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention