BEUDAMED
    FDA Adverse Event Death Summary report: N

    POLYAXIAL PLATE

    MDR report key: 1941961 · Received December 22, 2010

    Report

    Report Number
    1818910-2010-09968
    Event Type
    Death
    Date Received
    December 22, 2010
    Date of Event
    November 14, 2010
    Report Date
    November 22, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DEATH OF PT, COMPLAINT REPORTED BY (B)(6). THE PT (B)(6). WAS (B)(6) AND HAD AN EXTENSIVE MEDICAL HISTORY AND CO-MORBIDITIES (HYPERTENSION, STROKES, STAGE IV CHRONIC KIDNEY DISEASE, PREVIOUS HIP FRACTURES, CHRONIC OBSTRUCTIVE AIRWAY DISEASE AND MASTECTOMIES) WHO HAD THIS DEVICE IMPLANTED ON (B)(6) 2010 FOR THE FIXATION OF HER DISTAL FEMORAL FRACTURE. WHILST AN IN-PT, THE HEALING OF HER SURGICAL WOUND WAS SATISFACTORY AND AFTER A PERIOD OF IN-PT REHAB, SHE WAS DISCHARGED TO A COMMUNITY REHAB BED ON THE (B)(6) 2010. UNFORTUNATELY SHE WAS RE-ADMITTED WITH SYMPTOMS SUGGESTIVE OF A STROKE AND WOUND INFECTION ON THE (B)(6) 2010, ONE DAY POST-DISCHARGE AND 17 DAYS POST-OPERATIVELY. CT HEAD ON THE (B)(6) 2010, SHOWED NO NEW SIGNS OF HEMORRHAGE, BUT OLD CHANGES IN THE CEREBRAL AND FRONTAL CONSISTENT WITH PREVIOUS STROKES AND GENERAL CEREBRAL ATROPHY. SHE HAD TWO OPERATIONS TO DEBRIDE THE AFFECTED SECTION OF HER WOUND, DRAIN AND WASH OUT THE LOCAL COLLECTION OF PUS ON THE (B)(6) 2010 AND (B)(6) 2010. SHE WAS TREATED WITH ANTIBIOTICS INTRAVENOUSLY FOR A MULTI-SENSITIVE (B)(6) CULTURE FROM HER SURGICAL WOUND. POST-OPERATIVELY, SHE HAS TWO UNITS OF RED CELLS TRANSFUSION FOR ANEMIA AND DEVELOPED ACUTE-ON-CHRONIC RENAL FAILURE, RESPIRATORY FAILURE FORTUNATELY DETERIORATED AND DIED ON THE (B)(6) 2010, WHILST UNDER ACTIVE MGMT. HER FAMILY WERE KEPT INFORMED OF HER CONDITION THROUGH ALL THE STAGES OF HER CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYAXIAL PLATE TRAUMA DEVICE HRS DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| R