BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP INTLK FEMORAL LT 55

    MDR report key: 7148046 · Received December 27, 2017

    Report

    Report Number
    0001825034-2017-10910
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    March 18, 2016
    Report Date
    December 5, 2017
    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
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT - (B)(4). CONCOMITANT PRODUCTS: CAT#195751; LOT#833150 - VANG XP INLK PRI TIB TRAY 63MM. CAT#195807; LOT#759920 - VGXP XP LAT TIB BRG LT 9X63. CAT#195877; LOT#891500 - VGXP XP MED TIB BRG LT 9X63. RELATED MFR REPORTS: 0001825034-2017-10911, 0001825034-2017-10912, 0001825034-2017-10913. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A REVIEW OF THE OPERATIVE RECORD INDICATES THAT THE SURGEON NOTED TIBIAL ISLAND DIDN'T STAY INTACT THROUGH FULL EXTENSION DURING TRIALING. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT KNEE SURGERY ON (B)(6) 2016. THE OPERATIVE RECORD INDICATED TIBIAL ISLAND DID NOT STAY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927042 VGXP INTLK FEMORAL LT 55 PROSTHESIS - KNEE MBH ZIMMER BIOMET, INC. N/A 498450

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other