BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIMA HIP

    MDR report key: 2574191 · Received May 9, 2012

    Report

    Report Number
    1644408-2012-00251
    Event Type
    Other
    Date Received
    May 9, 2012
    Date of Event
    April 27, 2012
    Report Date
    April 27, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT WAS HIKING ON ROCKY TERRAIN AND FELL, CAUSING THE LIMA CAGE TO FAIL. THE DOCTOR REMOVED THE ORIGINAL SHELL ON (B)(6) 2009. THE HXL/FMP LINER, BIOLOX HEAD, BIOLOX SLEEVE, AND LIMA CAGE WERE REMOVED DURING A REVISION SURGERY PERFORMED ON (B)(6) 2010. THE SURGEON REPLACED WITH ANOTHER DJO BIOLOX HEAD AND SLEEVE, BUT USED COMPETITOR'S SHELL AND LINER. THE ORIGINAL STEM IMPLANTED IN THE PRIMARY SURGERY WAS RETAINED IN THE PATIENT. THE AGENT REPORTED THE DJO PRODUCT WAS NOT THE CAUSE OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIMA HIP ACETABULAR CAGE, STD .54MM KWA ENCORE MEDICAL, L.P. 1006886

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention 400-05-000, LOT 53998461| 430-01-050, LOT 53946265| 400-04-360, LOT 53990784| 932-36-252, LOT 54015495