BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CERMAIC ACETABULAR INLAY

    MDR report key: 3812622 · Received May 6, 2014

    Report

    Report Number
    9613350-2014-03493
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MDR WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT WAS IMPLANTED ON LEFT SIDE A CEMENTLESS HIP TEP (EXACT PRODUCT INFORMATION NOT REPORTED) ON (B)(6), 2003 DUE TO NECROSIS OF FEMORAL HEAD. THEN ON (B)(6), 2014 PATIENT UNDERWENT REVISION SURGERY DUE TO SPONTANEOUS BREAKAGE OF CERAMIC INLAY. IT IS ALSO REPORTED THAT PATIENT'S BUILD AND ACTIVITY LEVEL ARE MEDIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271811 UNKNOWN CERMAIC ACETABULAR INLAY UNKNOWN KWA ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R