BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEFT KNEE REPLACEMENT

    MDR report key: 1833112 · Received September 9, 2010

    Report

    Report Number
    2249697-2010-01199
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    January 15, 2008
    Report Date
    August 19, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAY
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "IT WAS REPORTED BY THE PT THAT HE HAD BILATERAL KNEE REPLACEMENT IN (B)(6) 2008. EVER SINCE THE SURGERY, HE HAS BEEN FEELING SORE, EXPERIENCING TIGHTNESS AND HEARING CLICKING IN HIS KNEES. ALSO WHEN WALKING SOMETIMES HIS KNEES LOCK UP AND HE FEEL LIKE HE IS GOING TO FALL. PT FOLLOWED UP WITH HIS SURGEON AND ALSO REC'D TWO OTHER OPTIONS, HE WAS TOLD HIS KNEE REPLACEMENT LOOKED FINE BUT SURGEONS ALSO SUGGESTED FOR THE PT TO HAVE A REVISION. PT WOULD LIKE AN INVESTIGATION DONE, HOPING TO FIND OUT WHY HE IS HAVING THESE ISSUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEFT KNEE REPLACEMENT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other