BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZIMMER MMC CUP 58MM/50MM CODE P

    MDR report key: 3221818 · Received July 9, 2013

    Report

    Report Number
    9613350-2013-01709
    Event Type
    Other
    Date Received
    July 9, 2013
    Date of Event
    May 30, 2012
    Report Date
    June 24, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. OTHER SOURCE DOCUMENTS (SURGICAL REPORT) WERE PROVIDED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, AS THE PATIENT HAS NOT BEEN REVISED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A ZIMMER MMC CUP 58MM/50MM CODE P ON THE LEFT SIDE ON (B)(6) 2010. TO DATE, THE PATIENT HAS NOT BEEN REVISED. CURRENTLY, THE PATIENT IS BEING MONITORED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312433 ZIMMER MMC CUP 58MM/50MM CODE P ZIMMER MMC CUP JDI ZIMMER GMBH 2522494

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other