BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRH XS/S/M LONG XOVER

    MDR report key: 3285618 · Received August 14, 2013

    Report

    Report Number
    0002249697-2013-02680
    Event Type
    Injury
    Date Received
    August 14, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K002552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. PRODUCT NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SOFT TISSUE INGROWTH INTO THE CENTRAL PART OF THE HINGE MECHANISM INVOLVING A MRH XOVER COMPONENT WAS REPORTED. THIS EVENT RELATES TO SOFT TISSUE INGROWTH OF THE PATIENT INTO THE CENTRAL PART OF THE HINGE MECHANISM WHICH LED TO PAIN. THE REPORTED BUSHINGS, AXLE, TIBIAL BEARING AND BUMPERS WERE EXPLANTED. IT IS CONSIDERED GOOD PRACTICE TO CHANGE OUT POLY COMPONENTS DURING REVISION SURGERY. A MEDICAL REVIEW WAS NOT POSSIBLE WITH THE LIMITED INFORMATION PROVIDED. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS GMRS DISTAL FEMUR. SURGEON FEELS THAT THE BUSHINGS NEED TO BE CHANGED. EXPLORATORY SURGERY SCHEDULED FOR (B)(6) 2012. ADDITIONAL EVENT DESCRIPTION:IT WAS REPORTED THAT THE PATIENT HAS SOFT TISSUE INGROWTH INTO THE CENTRAL PART OF THE HINGE MECHANISM THAT LED TO PAIN. THE BUSHING, AXLE, TIBIAL BEARING, AND BUMPERS WERE CHANGED OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS GMR'S DISTAL FEMUR. SURGEON FEELS THAT THE BUSHINGS NEED TO BE CHANGED. EXPLORATORY SURGERY SCHEDULED FOR (B)(6). ADDITIONAL EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT HAS SOFT TISSUE INGROWTH INTO THE CENTRAL PART OF THE HINGE MECHANISM THAT LED TO PAIN. THE BUSHING, AXLE, TIBIAL BEARING, AND BUMPERS WERE CHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392760 MRH XS/S/M LONG XOVER IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH J67982

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention