BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOLOGY SALVAGE SYSTEM- OSS TIBIAL BUSHING

    MDR report key: 6523166 · Received April 26, 2017

    Report

    Report Number
    0001825034-2017-02858
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    February 24, 2015
    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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS ¿ OSS LOCKING PIN, CATALOG: 150478, LOT: 360630; OSS FEMORAL BUSHINGS, QTY. 2 , CATALOG: 150477, LOT: 525090; OSS 18 MM TIBIAL BEARING, CATALOG: 150413, LOT: 221680; OSS YOKE, CATALOG: 150493, LOT: 245680; OSS AXLE, CATALOG: 150480, LOT: 538340; OSS TIBIAL AUGMENT, CATALOG: 150427, LOT: 199970; OSS RESURFACING FEMORAL 3 CM LEFT, CATALOG: 150350, LOT: 287150; OSS NON-MODULAR TIBIAL PLATE, CATALOG: 161043, LOT: 003420; OSS IM STEM 13 MM X 150 MM, CATALOG: 150367, LOT: 507710; 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: 1825034-2017-02857, 1825034-2017-02859, AND 1825034-2017-02860.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY THREE 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
    303046 ONCOLOGY SALVAGE SYSTEM- OSS TIBIAL BUSHING PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS 724250 

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R