BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT HV W/ GENTAMICIN POWDER BONE CEMENT 40 GRAMS

    MDR report key: 6908074 · Received October 2, 2017

    Report

    Report Number
    0001825034-2017-07666
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    January 31, 2017
    Report Date
    September 30, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    PK051532
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    :CONCOMITANT MEDICAL PRODUCTS: ITEM: ONCOLOGY SALVAGE SYSTEM STEM, ITEM NUMBER: 150376, LOT: 109260, ITEM: ONCOLOGY SALVAGE SYSTEM STEM, ITEM NUMBER: 150364, LOT: 618620, ITEM: ONCOLOGY SALVAGE SYSTEM MODULAR TIB BASE, ITEM NUMBER: 150422, LOT: 250040, ITEM: ONCOLOGY SALVAGE SYSTEM AXLE, ITEM NUMBER: 150480, LOT: 350830, ITEM: ONCOLOGY SALVAGE SYSTEM TIBIAL BEARING, ITEM NUMBER: 150412, LOT: 795550, ITEM: ONCOLOGY SALVAGE SYSTEM FEMORAL BUSHING, ITEM NUMBER: 150477, LOT: 231550, ITEM: ONCOLOGY SALVAGE SYSTEM REINFORCED YOKE, ITEM NUMBER: 150493, LOT: 141110, ITEM: ONCOLOGY SALVAGE SYSTEM POLY TIBIAL BUSHING, ITEM NUMBER: 150476, LOT: 161350, ITEM: ONCOLOGY SALVAGE SYSTEM POLY LOCK PIN, ITEM NUMBER: 150478, LOT: 141290 ITEM: OPTIVAC TOTAL HIP KIT, ITEM NUMBER: 417000, LOT: 0000747093, ITEM: COBALT G-HV BONE CEMENT, ITEM NUMBER: 402283, LOT: 627260, ITEM: COBALT G-HV BONE CEMENT, ITEM NUMBER: 402283, LOT: 627260. THE COMPLAINT SAMPLE WAS EVALUATED, BUT THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-01513 / 01514.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REVISION OF AN ONCOLOGY SALVAGE SYSTEM KNEE 4 YEARS POST-OPERATIVELY DUE TO LOOSENING OF THE FEMORAL COMPONENTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686769 COBALT HV W/ GENTAMICIN POWDER BONE CEMENT 40 GRAMS CEMENT, BONE LOD ZIMMER BIOMET, INC. N/A 627260

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R