BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOLOGY SALVAGE SYSTEM - OSS RESURFACING FEMORAL 3CM LEFT

    MDR report key: 6523136 · Received April 26, 2017

    Report

    Report Number
    0001825034-2017-02854
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    January 27, 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 695070; OSS TIBIAL BUSHING CATALOG 150476 LOT 149170; OSS FEMORAL BUSHINGS QTY. 2 CATALOG 150477 LOT 215530; OSS AXLE CATALOG 150480 LOT 106670; OSS YOKE CATALOG 150493 LOT 834080; OSS INTERLOK BOWED IM STEM W/SCREW 15MM X 150MM CATALOG 150369 LOT 999000; OSS 14MM TIBIAL BEARING CATALOG 150411 LOT 673420; OSS NON-MODULAR PROXIMAL TIBIAL CATALOG 150805 LOT 623670 BIOMET PATELLA CATALOG 11-150844 LOT 669340 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: 1825034-2017-02848, 1825034-2017-02849, 1825034-2017-02850, 1825034-2017-02851, 1825034-2017-02852, 1825034-2017-02853, 1825034-2017-02855, AND 1825034-2017-02856.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY ONE YEAR 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
    306041 ONCOLOGY SALVAGE SYSTEM - OSS RESURFACING FEMORAL 3CM LEFT PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS 319140 

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R