BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FITMORE HIP STEM B EXT OFFS, SIZE 7

    MDR report key: 2852389 · Received November 27, 2012

    Report

    Report Number
    9613350-2012-01105
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    July 13, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE EXPLANTED DEVICES FOR REVIEW. THE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, AND THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED A FITMORE HIP STEM B EXT SIZE 7 ON (B)(6) 2011, AND UNDERWENT REVISION SURGERY ON (B)(6) 2012, DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FITMORE HIP STEM B EXT OFFS, SIZE 7 ZIMMER POROLOCK MIS STEM KWA ZIMMER GMBH 2601341

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R