BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOLOGY SALVAGE SYSTEM- TIBIAL BEARING

    MDR report key: 6518132 · Received April 25, 2017

    Report

    Report Number
    0001825034-2017-02798
    Event Type
    Injury
    Date Received
    April 25, 2017
    Date of Event
    March 30, 2017
    Report Date
    April 25, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S): CATALOG #: 150476, LOT#: 919050. CATALOG#150480, LOT#510900. CATALOG#:178512, LOT#: 094770. CATALOG#: 150478, LOT#782900. CATALOG#150477, LOT#744400. CATALOG#178530, LOT# 500880. CATALOG#: 178546, LOT#009540. CATALOG #: 150424, LOT#: 257850. CATALOG# 178358, LOT#: 502600. CATALOG#: 150428, LOT#: 682510. CATALOG#: 178412, LOT#: 016990. CATALOG #: 150389, LOT: 645760. CATALOG#: 150428, LOT#:667990. CATALOG#: 178712, LOT# 507370. CATALOG #150493, LOT#: 029530. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT REVISION OF AN OSS KNEE APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO DISLOCATION. THE BEARING WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300820 ONCOLOGY SALVAGE SYSTEM- TIBIAL BEARING PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS 988170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention