BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER CORPORATION

    MDR report key: 3242762 · Received July 17, 2013

    Report

    Report Number
    MW5030970
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    April 29, 2009
    Report Date
    July 17, 2013
    Manufacturer
    STRYKER ORTHOPEDICS
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD REVISION OF A RIGHT HIP REPLACEMENT ON (B)(6) 2009. AFTER YEARS OF PAIN AND DISABILITY, IN 2012, I WENT BACK TO MY SURGEON. HE PERFORMED ANOTHER REVISION AND SAID THAT THERE HAD NEVER BEEN ANY BONE GROWTH INTO THE ACETABULAR CUP. HE DID NOT DIAGNOSE THE NONUNION WHEN I WENT TO HIP WITH THIGH PAIN IN FALL OF 2009. IN (B)(6) 2012, HE SAID THE NONUNION WAS DUE TO THAT FACT THAT HE "DID NOT SEAT IT RIGHT." I DON'T KNOW IF HE IS COVERING UP FOR STRYKER BECAUSE HE IS A HIGHLY PAID CONSULTANT FOR THEM. DATES OF USE: (B)(6) 2009 - (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332109 STRYKER CORPORATION ACETABULAR CUP KWA STRYKER ORTHOPEDICS METPW3
    332110 STRYKER CORPORATION CLUSTER HOLE SHELL JDI STRYKER ORTHOPEDICS MHDA04
    332413 TORX BONE SCREW BONESCREW HWC STRYKER ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other