BEUDAMED
    FDA Adverse Event Death Summary report: N

    HARRIS PRECOAT FEMORAL STEM

    MDR report key: 302165 · Received October 25, 2000

    Report

    Report Number
    1822565-2000-00102
    Event Type
    Death
    Date Received
    October 25, 2000
    Date of Event
    April 6, 1999
    Report Date
    October 16, 2000
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 1993 PT UNDERWENT LEFT TOTAL HIP REPLACEMENT. IN 1999, X-RAYS REVEALED LOOSENING OF THE STEM AND THINNING OF THE LATERAL CORTEX. IN 1999, THE PT'S PHYSICIAN RECOMMENDED REVISION. PT ELECTED TO POSTPONE THE SURGERY BECAUSE OF OTHER UNRELATED COMPLICATING HEALTH FACTORS. A FEW WEEKS LATER, IN 1999, THE PT TRIPPED OVER PT'S DOG'S LEASH AND FELL 1 FT FROM A PORCH. IMMEDIATELY, PT EXPERIENCED INCREASED PAIN AND POPPING IN THE HIP AND WAS UNABLE TO BEAR WEIGHT ON THE LEFT SIDE. THE PT WAS ADMITTED TO THE HOSP AND NEEDED REVISION SURGERY. PT AGAIN ELECTED TO POSTPONE BECAUSE OF OTHER UNRELATED HEALTH FACTORS. IN 1999, PT WAS ADMITTED TO THE HOSP FOR LEFT HIP PAIN AND ELECTIVELY UNDERWENT REVISION OF THE HIP WHERE IT WAS NOTED THE STEM HAD FRACTURED AND WAS GROSSLY LOOSE. DURING THE PROCEDURE, PT DID WELL AND POST OPERATIVELY PROGRESSED VERY WELL WITHOUT COMPLICATION. IN 1999 PT WAS ADMITTED TO A REHAB FACILITY WHERE THE PT DIED ON 12/9/1999 AS A RESULT OF SEPTICEMIA/RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARRIS PRECOAT FEMORAL STEM HIP PROSTHESIS KWY ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R