BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 4 HOLE SHELL 54MM F 4MM F

    MDR report key: 10586152 · Received September 25, 2020

    Report

    Report Number
    0001825034-2020-03631
    Event Type
    Injury
    Date Received
    September 25, 2020
    Date of Event
    May 20, 2020
    Report Date
    September 25, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 PRODUCT REMAINS IMPLANTED.CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 193011, ITEM NAME: ECHO BI-METRIC STEM, LOT NUMBER: 995030, ITEM NUMBER: 30103606, ITEM NAME: G7, LINER NEUTRAL LOT NUMBER: 64319477, ITEM NUMBER: 650-0660, ITEM NAME: DELTA CERAMIC FEMORAL HEAD, LOT NUMBER: 3030546. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 03630 . REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED ZIMMER BIOMET DEVICE. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT. DEEP VEIN THROMBOSIS, OR DVT, OCCURS WHEN A BLOOD CLOT FORMS IN ONE OF THE DEEP VEINS OF THE BODY. THIS CAN HAPPEN IF A VEIN BECOMES DAMAGED OR IF THE BLOOD FLOW WITHIN A VEIN SLOWS DOWN OR STOPS. TOTAL JOINT PATIENTS ARE TYPICALLY PLACED ON MEDICATION POST-OPERATIVE FOR A PERIOD OF TIME TO PREVENT THE DEVELOPMENT OF DVT/BLOOD CLOT. EVEN WITH THE ADMINISTRATION OF PREVENTIVE MEDICATION AND EQUIPMENT, DVT/BLOOD CLOTS CAN STILL DEVELOP. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED AN ACUTE RIGHT FEMORAL VEIN DEEP VEIN THROMBUS (DVT) ONE DAY POST INITIAL HIP SURGERY. PRODUCTS REMAIN IMPLANTED. PATIENT WAS PLACE ON FOOT PUMP/COMPRESSION DEVICE, COMPRESSION STOCKINGS AND APIXABAN TO RESOLVE THE ADVERSE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052161 G7 OSSEOTI 4 HOLE SHELL 54MM F 4MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6725596

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention