BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL HEAD 28 L 12/14

    MDR report key: 3708455 · Received March 14, 2014

    Report

    Report Number
    9613350-2014-03370
    Event Type
    Injury
    Date Received
    March 14, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE X-RAYS OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICES HAVE BEEN RECEIVED AND THE INVESTIGATION HAS BEEN INITIATED. 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 INFO PROVIDED. SHOULD ADD'L INFO 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 PT WAS IMPLANTED A METASUL HEAD 28 L 12/14 ON THE RIGHT SIDE ON UNK DATE. THE PT WAS REVISED ON UNK DATE DUE TO OSTEOLYSIS. THE FOLLOWING INFO WAS STATED: CR: < 0.50 MIKROG/L CO: 0.93 MIKROG/L. MO: 0.98 MIKROG/L. IN 2010, SIGNS OF LOOSENING (OSTEOLYSIS) BRIGHTENING SEAM, LITTLE DISCOMFORT. (B)(6) 2013, REVISION, HTEP REVISION, STEM AND INLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154931 METASUL HEAD 28 L 12/14 METASUL HEAD KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R