BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO PS FEMUR WAFFLE POSTS W/LFIT

    MDR report key: 2252820 · Received September 13, 2011

    Report

    Report Number
    2249697-2011-01330
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    March 26, 2010
    Report Date
    August 18, 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
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER KNEE DEVICES WERE ALSO LISTED IN THIS REPORT: SERIES 7000 STANDARD TIBIA, CAT# 7115-0007, LOT# MHRL85; SCORPIO TOTAL KNEE PS TIBIAL BEARING INSERT, CAT# 72-13-0708, LOT# 32350501, SCORPIO M-DOME PATELLA, CAT# 73-0910, LOT# 0B50; SIMPLEX TOBRAMYCIN 1 PK, CAT# 6197-1-001, LOT# TLQ072. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO WAS REQUESTED. SHOULD IT BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED: "PT HAD HER KNEE REPLACEMENT DONE ON (B)(6) 2010. AFTER HER SURGERY, SHE BEGAN TO EXPERIENCE SWELLING AND EXCESSIVE PAIN. THREE MONTHS AFTER THE SURGERY, SHE HAD A POST OP VISIT WITH HER SURGEON AND SHE DISCUSSED HER EXPERIENCES BUT SHE WAS TOLD THAT IT WAS NORMAL TO HAVE PAIN AND SWELLING AFTER MAJOR SURGERY; SINCE THEN HER PAIN NEVER WENT AWAY. IN (B)(6) 2011, SHE DEVELOPED A TOOTH ABSCESS AND WAS PUT ON ANTIBIOTICS, ONCE SHE STARTED TAKING THE ANTIBIOTICS, SHE NOTICED A CHANGE IN HER KNEE. IT FELT LIKE IT SHE WAS IMPROVING. SHE MET WITH A SECOND SURGEON DR. S. AND WAS TOLD THAT HER IMPLANTS WERE LOOSE. SHE TOLD THE SURGEON ABOUT THE ANTIBIOTICS AND THE DIFFERENCE SHE FELT AFTER TAKING THEM. HE SENT HER FOR A WHITE BLOOD SCAN ON (B)(6) 2011, BUT THERE WERE NO SIGNS OF INFECTION. DR. (B)(6) TOLD THE PT THAT SHE IS IN NEED OF A REVISION. PT WANTED TO KNOW IF THERE HAVE BEEN OTHER INCIDENCES LIKE HERE AND WHY SHE HAS BEEN EXPERIENCING PAIN AND SWELLING. SHE STATED THAT SHE WAS AN ATHLETIC PERSON AND HER MEANS OF TRANSPORTATION WAS HER BICYCLE, NOW SINCE THE SURGERY SHE NEEDS A CANE TO WALK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO PS FEMUR WAFFLE POSTS W/LFIT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA MHPLR9

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other