BEUDAMED
    FDA Adverse Event Other Summary report: N

    M-COR HIP STEM SYSTEM

    MDR report key: 1027484 · Received April 9, 2008

    Report

    Report Number
    9613642-2008-00051
    Event Type
    Other
    Date Received
    April 9, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    PORTLAND ORTHOPAEDICS PTY. LTD.
    Product Code
    KWY
    PMA / PMN Number
    K053417
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRIMARY HIP REPLACEMENT USING A M-COR HIP REPLACEMENT SYSTEM AND ANOTHER MANUFACTURER'S ACETABULAR CUP SYSTEM WAS PERFORMED ON A PT IN 2008. THE PT PRESENTED WITH A DISLOCATED HIP 14 DAYS AFTER INITIAL SURGERY. THE DISLOCATION, ACCORDING TO THE SURGEON, WAS DUE TO A NON-COMPLIANT PT SITTING DOWN INTO A VERY LOW CHAIR. FOLLOWING THE DISLOCATION, THE SURGEON ELECTED TO REPLACE THE ACETABULAR CUP, WHICH ALSO REQUIRED THE M-COR SYSTEM FEMORAL NECK AND HEAD TO BE REMOVED TO GAIN BETTER ACCESS TO THE CUP. DURING INSERTION AND REMOVAL OF MODULAR HIP REPLACEMENT COMPONENTS, THERE IS THE POSSIBILITY FOR DAMAGE TO MATING (TAPER) SURFACES. AS A PRECAUTION, THE NECK AND HEAD WERE ALSO REPLACED DURING THE REVISION PROCEDURE. THE M-COR FEMORAL STEM WAS LEFT IN PLACE. THE DECISION BY THE SURGEON TO CONDUCT THE REVISION SURGERY IN THIS CASE WAS NOT RELATED TO THE M-COR STEM DEVICES. THE REVISION SURGERY WAS SUCCESSFUL. THE SURGEON COMMENTED THAT HE WAS COMPLETELY SATISFIED WITH THE STABILITY OF THE PATIENT'S HIP POST-OPERATIVELY.

    Description of Event or Problem · 1

    PT WITH AN M-COR REPLACEMENT SYSTEM PRESENTED WITH A DISLOCATED HIP AFTER SITTING DOWN INTO A VERY LOW CHAIR. THE PT HAD THE PRIMARY TOTAL HIP REPLACEMENT PROCEDURE WITH AN M-COR HIP SYSTEM AND ANOTHER MANUFACTURER'S ACETABULAR CUP SYSTEM 14 DAYS PRIOR TO THE DISLOCATION. FOLLOWING THE DISLOCATION, THE SURGEON ELECTED TO REPLACE THE ACETABULAR CUP, WHICH ALSO REQUIRED THE M-COR SYSTEM FEMORAL NECK AND HEAD TO BE REMOVED TO GAIN BETTER ACCESS TO THE CUP. AS A PRECAUTION FOR ENGINEERING REASONS, THE NECK AND HEAD WERE ALSO REPLACED DURING THE REVISION PROCEDURE. THE M-COR FEMORAL STEM WAS LEFT IN PLACE. THIS EVENT WAS NOT RELATED TO THE M-COR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M-COR HIP STEM SYSTEM FEMORAL NECK KWY PORTLAND ORTHOPAEDICS PTY. LTD. 2264

    Patients

    Seq Age Sex Outcome Treatment
    1 CERAMIC FEMORAL HEAD 32M| M-COR FEMORAL STEM 39X16, LOT # 2170