BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KRH BUSHING STANDARD

    MDR report key: 1731304 · Received June 18, 2010

    Report

    Report Number
    2249697-2010-00695
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    May 27, 2010
    Report Date
    May 27, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K792089
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: TIB BEARING COMP ROT/HIN KNEE, CAT # 6475-3-933, LOT FXRWA; KRH STANDARD AXLE, CAT # 6475-3-940, LOT FWECB; MRS CONDYLE LT, CAT # 6485-0-010, LOT FTHWA; KRH BUSHING STANDARD, CAT # 6475-3-944, LOT TCP9733; KRH STANDARD BUMPER, CAT # 6485-3-100, LOT TCP9722. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS KEPT BY THE PT AND WAS NOT RETURNED TO THE MFR. ADD'L INFO INCLUDING X-RAYS AND MEDICAL RECORDS WAS REQUESTED. IF DEVICE OR ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PT HAD A REVISION DUE TO PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KRH BUSHING STANDARD IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA TCP9734

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention