BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOLOGY SALVAGE SYSTEM - OSS AXLE

    MDR report key: 6523168 · Received April 26, 2017

    Report

    Report Number
    0001825034-2017-02831
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    October 1, 2013
    Report Date
    April 26, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). CONCOMITANT PRODUCTS: OSS 18MM TIBIAL BEARING CATALOG 150413 LOT 221680; OSS LOCKING PIN CATALOG 150478 LOT 771660; OSS TIBIAL BUSHING CATALOG 150476 LOT 596510; OSS FEMORAL BUSHINGS QTY. 2 CATALOG 150477 LOT 573080; OSS YOKE CATALOG 150493 LOT 477300. BIOMET PATELLA CATALOG 11-150844 LOT 669340; OSS FEMUR CATALOG 150351 LOT 822360; OSS TIBIAL PLATE CATALOG 150420 LOT 942620; OSS TIBIAL AUGMENT CATALOG 150426 LOT 218000; OSS IM STEM CATALOG 150372 LOT 671210; OSS TIBIAL AUGMENT CATALOG 150426 LOT 218000. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2017-02827, 1825034-2017-02828, 1825034-2017-02829, 1825034-2017-02830, AND 1825034-2017-02832.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303049 ONCOLOGY SALVAGE SYSTEM - OSS AXLE PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS 743490

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE