BEUDAMED
    FDA Adverse Event Summary report: N

    ACCUFILL

    MDR report key: 5008700 · Received August 17, 2015

    Report

    Report Number
    3008812173-2015-00004
    Date Received
    August 17, 2015
    Date of Event
    July 22, 2015
    Report Date
    August 14, 2015
    Manufacturer
    ZIMMER ETEX
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    DURING A CHART REVIEW AT DR (B)(6) PRACTICE, THIS RANDOMLY SELECTED FILE HAD INDICATED THAT THE PATIENT HAD UNDERGONE A ZKC SUBCHONDROPLASTY PROCEDURE (B)(6) 2012. PER THE CHART NOTES, SHE WAS CONVERTED TO A TOTAL KNEE ARTHROPLASTY(BILATERAL) ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541933 ACCUFILL BONE VOID FILLER MQV ZIMMER ETEX 201.050

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other