BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD CON DIST STEM 17 X 155 MM

    MDR report key: 3984177 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03010
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K022549
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION DUE TO TUMOR ON THE FEMUR FROM RENAL CANCER INVOLVING A RESTORATION MODULAR STEM WAS REPORTED. CONCLUSION:THE REPORTED EVENT INDICATES THE PATIENT UNDERWENT A REVISION TO A GMRS SYSTEM, AS A TUMOR ORIGINATING FROM RENAL CANCER DEVELOPED ON THE PATIENT¿S FEMUR. THERE IS NO ALLEGED FAILURE OF THE REPORTED STEM. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 6570-0-128, LOT # UNKNOWN, DESCRIPTION: PRIMARY DELTA V-40 CERAMIC HEAD 28/0. CAT # 1236-2-852, LOT # UNKNOWN, DESCRIPTION: RESTORATION ADM X3 INS 28/52. CAT # 6276-1-125, LOT # 43444201, DESCRIPTION: 25MM MOD REV HIP BDY/BLT +10MM COMPONENT LEVEL 9006-1-125. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. PATIENT RETAINED DEVICES.

    Description of Event or Problem · 1

    PATIENT DEVELOPED TUMOR IN PROXIMAL FEMUR FROM RENAL CANCER. REMOVED MOD RESTORATION STEM, 28 HEAD AND MDM POLY INSERT. IMPLANTED GMRS PROXIMAL FEMUR WITH NEW V40 HEAD AND MDM INSERT

    Description of Event or Problem · 1

    PATIENT DEVELOPED TUMOR IN PROXIMAL FEMUR FROM RENAL CANCER. REMOVED MOD RESTORATION STEM, 28 HEAD AND MDM POLY INSERT. IMPLANTED GMRS PROXIMAL FEMUR WITH NEW V40 HEAD AND MDM INSERT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460774 MOD CON DIST STEM 17 X 155 MM IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R