BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X45MM

    MDR report key: 7778669 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-08093
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    May 28, 2018
    Report Date
    August 13, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAS BEEN DISCARDED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: ITEM # S061140, FEMORAL HEAD, LOT # 994990; ITEM # 472370, DRILL BIT, LOT # 100960; ITEM # 31-323220, DRILL BIT, LOT # 991390; ITEM # 31-323230 DRILL BIT, LOT # 991490; ITEM # CP161944, SCREW, LOT # 790470; ITEM #103536, SCREW, LOT # 941760; ITEM # CP161943, SCREW, LOT # 442990; ITEM #103535, SCREW, LOT # 991290; ITEM #103535, SCREW, LOT # 530910; ITEM # EP-108424, LINER, LOT # 305730; ITEM # 472370, DRILL BIT, LOT # 394450; ITEM # CP161945, SCREW, LOT # 796170; ITEM # CP161944, SCREW, LOT # 741690; ITEM # 103534, SCREW, LOT # 568430; ITEM # UNK, HIP-UNKNOWN-STEMS-UNK, LOT # UNK; ITEM # PMI157449, TRIFLANGE ACETABULAR CUP, LOT # 586700. MULTIPLE REPORTS ARE BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03106, 0001825034-2018-08092, 0001825034-2018-08093, 0001825034-2018-08094, 0001825034-2018-08095, 0001825034-2018-08096, 0001825034-2018-08097, 0001825034-2018-08098, 0001825034-2018-08099, 0001825034-2018-08100.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO DEVICE LOOSENING AND FRACTURED SCREWS. RECORDS INDICATE PATIENT HAS AN ACETABULAR DEFECT THAT CANNOT BE MANAGED WITH TRADITIONAL ACETABULAR CUPS. THEREFORE, A TRIFLANGE ACETABULAR COMPONENT WAS DESIGNED FOR THE PRIMARY AND REVISION SURGERIES. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619652 TI LOW PROFILE SCREW 6.5X45MM HIP FIXATION KWA ZIMMER BIOMET, INC. N/A 105150

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R