BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER CEMENTED ACETABULAR GENERIC

    MDR report key: 2932483 · Received January 24, 2013

    Report

    Report Number
    1822565-2013-00164
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE EXPLANTED DEVICE FOR REVIEW. AS NEITHER ARTICLE NOR LOT NUMBER IS KNOWN, THE REVIEW OF THE QUALITY RECORDS COULD NOT BE PERFORMED. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. HOWEVER, THERE IS NO INDICATION FOR A PRODUCT FAILURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE 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 CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED ZIMMER CEMENTED ACETABULAR GENERIC. THE ACETABULAR COMPONENT WAS REVISED DUE TO LOOSENING. IT IS FURTHER REPORTED THAT THE LOOSENING HAS LASTED FOR A YEAR. THE METASUL COMPONENTS WERE REVISED AS WELL ON (B)(6)2013. THERE IS NO INDICATION OF A POSSIBLE REVISION OF THE STEM. THE POSITIONING OF THE ACETABULAR COMPONENT WAS ANTEVERSION 45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34573 ZIMMER CEMENTED ACETABULAR GENERIC ZIMMER CEMENTED ACETABULAR GENERIC JDI ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R