BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER MMC CUP 52MM/44MM CODE J

    MDR report key: 2041306 · Received March 25, 2011

    Report

    Report Number
    9613350-2011-00174
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT ZIMMER INC., WHICH MARKETS THE DEVICES IN (B)(4). THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE REC'D FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER GMBH CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT ONE YEAR POST-OP THE PT IS COMPLAINING OF PAIN. SINCE THIS TIME, PT HAS BEEN SENT FOR ASPIRATION AND ANALYSIS AND WAS REVISED. IT IS ALSO REPORTED THAT NO INFECTION HAS BEEN NOTED AND THE FLUID APPEARS CONSISTENT WITH METAL-ON-METAL DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER MMC CUP 52MM/44MM CODE J ZIMMER MMC CUP KWA ZIMMER GMBH 2505064

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention