BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIM BP W/HOLES BEAD W/PA SZ 4

    MDR report key: 3381071 · Received October 2, 2013

    Report

    Report Number
    0002249697-2013-03170
    Event Type
    Injury
    Date Received
    October 2, 2013
    Date of Event
    September 10, 2013
    Report Date
    September 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K072575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING A TRIATHLON BASEPLATE COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE COMPONENT WAS NOT RETURNED FOR REVIEW. A DHR REVIEW COULD NOT BE PERFORMED AS THE LOT ID IS UNKNOWN. DHR REVIEW COULD NOT BE PERFORMED AS THE LOT ID IS UNKNOWN. THE REPORTED EVENT CANNOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED. 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

    IT WAS REPORTED THAT THE BASEPLATE CAME LOOSE. REPLACED WITH A CEMENTED BASEPLATE WITH A STEM. CHANGED POLY INSERT AND PATELLA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BASEPLATE CAME LOOSE. REPLACED WITH A CEMENTED BASEPLATE WITH A STEM. CHANGED POLY INSERT AND PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497198 PRIM BP W/HOLES BEAD W/PA SZ 4 IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention