BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM MS-30 10, POLISHED

    MDR report key: 1947652 · Received December 23, 2010

    Report

    Report Number
    9613350-2010-00597
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER, INC., WHICH MARKETS THE DEVICES IN THE UNITED STATES. THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, ARTICLE AND LOT NUMBER, OR OTHER SOURCE DOCUMENTS FOR REVIEW. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL 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 MS-30 STEM WAS REVISED DUE TO SEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEM MS-30 10, POLISHED MS-30 FEMORAL STEM KWY ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization