BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA PE INSERT WITH RIM

    MDR report key: 2091457 · Received May 4, 2011

    Report

    Report Number
    9613350-2011-00292
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4), WHICH MARKETS THE DEVICES IN (B)(4). THE MFR DID NOT YET RECEIVE DEVICES FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A MEASUREMENT CHECK WAS ACCOMPLISHED AND THE PRODUCTS WERE FOUND TO BE CORRECT. THIS INDICATES THAT NEITHER PRODUCT MALFUNCTION NOR MATERIAL FAILURE HAVE LEAD TO THE INCIDENT. SHOULD 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 (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE QUALITY OF HER BONES FOR A CEMENTFREE IMPLANT WAS OK. FITMORE CUP 50 MM WAS FOOD FIXED. TWO SCREWS IN THE TOP WERE IMPLANTED "FLAT". ALTHOUGH BOTH INLAYS WERE SEATED PROPPER, THEY WERE NOT ABLE TO BE FIXED IN THE CUP. FOR EACH INLAY, THERE WERE SEVERAL TRIALS TO FIX IT. LAST OPTION: BIGGER SHAPE 52MM- NEW FITMORE CUP SIZE 52MM AND USE OF CORRESPONDING PE-INLAY-IMMEDIATELY FIXATION WAS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA PE INSERT WITH RIM ALLOFIT ACETABULAR SYSTEM KWA ZIMMER GMBH 2567146

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization