BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP INTLK FEMORAL RT 60

    MDR report key: 7270489 · Received February 14, 2018

    Report

    Report Number
    0001825034-2018-00940
    Event Type
    Injury
    Date Received
    February 14, 2018
    Date of Event
    September 20, 2016
    Report Date
    February 14, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK141407
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT CMP-(B)(4). CONCOMITANT MEDICAL PRODUCTS: PART 195908, LOT 187410 - VGXP INTLK FEMORAL RT 60. PART 141223, LOT J3695863 ¿ BIOMET CC I-BEAM TRAY 71 MM, PART 183544, LOT 339880 - VNGD CR LIP TIB BRG 14X71/75 MM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MFR 0001825034-2018-00941, MFR 0001825034-2018-00942. 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    CLINICAL STUDY (B)(6) - 6 MONTH MODERATE PAIN POST OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113133 VGXP INTLK FEMORAL RT 60 PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 187410

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other