BEUDAMED
    FDA Adverse Event Other Summary report: N

    KERAMOS HIP

    MDR report key: 1943848 · Received December 22, 2010

    Report

    Report Number
    1644408-2010-00690
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    D980003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT COMPLAINED OF HIP PAIN AND DID NOT RESPOND TO CONSERVATIVE TREATMENT. AN X-RAY REVEALED THE ACETABULAR CUP HAD MIGRATED VERTICALLY TO APPROX 73 DEGREES (NORMAL IS 45). THE CUP WAS REMOVED AND REPLACED ALONG WITH THE FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERAMOS HIP FLARED SHELL LPH ENCORE MEDICAL, L.P. 282452

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention (B)(4), LOT 209492| (B)(4), LOT 952971K