BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-COR HIP STEM SYSTEM

    MDR report key: 1011906 · Received March 12, 2008

    Report

    Report Number
    9613642-2008-00002
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 12, 2008
    Manufacturer
    PORTLAND ORTHOPAEDICS PTY. LTD.
    Product Code
    KWY
    PMA / PMN Number
    K053417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PORTLAND ORTHOPAEDICS BELIEVES THAT THE RISK OF FRACTURE OF AN M-COR FEMORAL NECK CAUSING SERIOUS INJURY IS VERY REMOTE. A FRACTURE OF THE FEMORAL NECK WOULD ONLY OCCUR UNDER EXCESSIVE LOADS AS IN THIS CASE WHERE THE PT IS NOTED AS BEING OVERWEIGHT AND HAD SUFFERED A HEAVY FALL DIRECTLY ONTO THE AFFECTED HIP. THE FRACTURED FEMORAL NECK FROM THIS INCIDENT IS CURRENTLY BEING EVALUATED. PORTLAND ORTHOPAEDICS HAS INDICATED IN THE WARNING SECTION OF THE PRODUCT IFU THAT "PTS RECEIVING HIP JOINT REPLACEMENTS SHOULD BE ADVISED THAT THE LONGEVITY OF THE IMPLANT MAY DEPEND ON THE PT'S WEIGHT AND LEVEL OF ACTIVITY".

    Description of Event or Problem · 1

    ELEVEN MONTHS POSTOPERATIVELY, A PT WITH A BI-LATERAL PORTLAND ORTHOPAEDICS MCOR HIP REPLACEMENT, SLIPPED ON ICE FALLING ON HIS RIGHT HIP. ONE MONTH FOLLOWING THE FALL, THE PT FELT THE RIGHT HIP GIVE OUT FROM UNDER HIM. A PELVIC X-RAY WAS TAKEN, WHICH SHOWED A FRACTURE IN THE FEMORAL NECK OF THE TOTAL HIP REPLACEMENT. THE FEMORAL NECK AND STEM COMPONENTS WERE REVISED WITH ANOTHER HIP SYSTEM. AT THE TIME OF THE PRIMARY SURGERY AND AT THE TIME OF THE FALL ONE YEAR LATER, THE PT WAS NOTED AS BEING OVERWEIGHT. THE WEIGHT AND IMPACT DURING THE INCIDENT ARE LIKELY TO HAVE CONTRIBUTED TO THE EVENTUAL FRACTURE OF THE NECK. PORTLAND ORTHOPAEDICS ADVISES IN ITS LABELING THAT THE LONGEVITY OF THE IMPLANT MAY DEPEND ON THE PT'S WEIGHT AND LEVEL OF ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M-COR HIP STEM SYSTEM FEMORAL NECK KWY PORTLAND ORTHOPAEDICS PTY. LTD. 1547

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CERAMIC FEMORAL HEAD 32M| M-COR FEMORAL STEM 37X14