BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT BONE CEMENT

    MDR report key: 6862031 · Received September 13, 2017

    Report

    Report Number
    0001825034-2017-07080
    Event Type
    Injury
    Date Received
    September 13, 2017
    Date of Event
    April 10, 2017
    Report Date
    August 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CUSTOM TITANIUM CRUCIATE RETAINING FEMORAL, CAT#: CP113618, LOT#: 170070. BIOMET ILOK PRIMARY TIBIAL TRAY, CAT#: 141215, LOT#: 977050. BIOMET I-BEAM PRIMARY TIBIAL STEM, CAT#: 141310, LOT#: 974490. VANGUARD TIBIAL BEARING, CAT#: EP-183462, LOT#: 480970. BIOMET SERIES-A STANDARD PATELLA, CAT#: 184764, LOT#: 974490. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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: 0001825034-2017-07020, 0001825034-2017-07021, 0001825034-2017-07022, 0001825034-2017-07078, 0001825034-2017-07079.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE IS NOT REPORTABLE AS IT IS NOT MANUFACTURED BY ZIMMER BIOMET. THE PREVIOUSLY SUBMITTED REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS LOOSENING, INFECTION AND WEAR OF COMPONENTS. INTRAOPERATIVELY, METALLOSIS WAS NOTED IN THE JOINT AND SCRATCHES ON THE FEMORAL COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641372 COBALT BONE CEMENT PROSTHESIS, KNEE LOD ZIMMER BIOMET, INC. N/A 604040

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R