BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO M-DOME PATELLA

    MDR report key: 2062737 · Received April 13, 2011

    Report

    Report Number
    2249697-2011-00447
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    April 17, 2007
    Report Date
    March 17, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K962152
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: SCORPIO NRG PS FEMORAL #9 LEFT: CAT# 81-4409L, LOT# WYAMHA. NRG KNEE P/S NRG BEARING INSERT: CAT# 82-3-0710, LOT# UNK. SERIES 7000 STANDARD TIBIA: CAT# 7115-0007, LOT# P83MNA. AT THE PRESENT TIME IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN AND SUBSEQUENT REVISION. AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PATIENT STATED THAT AFTER HIS TOTAL KNEE REPLACEMENT EVERYTHING WAS GOING WELL UNTIL HE STARTED EXPERIENCING SWELLING AND PAIN. PT REACHED OUT TO HIS SURGEON AND THE SURGEON STATED THAT HIS KNEE WAS WORKING IT WAY LOOSE AND THE PT NEEDED A REVISION DONE. PT WAS REVISED ON (B)(6) 2011 AND WANTED TO KNOW IF HIS IMPLANTS WERE PART OF A RECALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO M-DOME PATELLA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA 12CEYC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention