BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZIMMER MMC CUP 60MM/52MM CODE R

    MDR report key: 2439538 · Received January 23, 2012

    Report

    Report Number
    9613350-2012-00045
    Event Type
    Other
    Date Received
    January 23, 2012
    Date of Event
    October 1, 2011
    Report Date
    January 4, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. 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 INFO PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ACETABULAR IMPLANT LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER MMC CUP 60MM/52MM CODE R ZIMMER MMC CUP KWA ZIMMER, INC. 2528358

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other