BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER NEUTRAL 36 MM I.D. SIZE F FOR USE WITH G7 ACETABULAR SYSTEM ONLY

    MDR report key: 10599096 · Received September 29, 2020

    Report

    Report Number
    0001822565-2020-03384
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    May 20, 2020
    Report Date
    September 29, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K190660
    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). CONCOMITANT MEDICAL DEVICES: 650-0660 ¿ DELTA CERAMIC HEAD ¿ 3030546; 110010245 ¿ G7 SHELL ¿ 6725596; 193011 ¿ ECHO STEM ¿ 995030. 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. AS THE COMPLAINT INDICATED A POST-OPERATIVE COMPLICATION OF ACUTE RIGHT FEMORAL VEIN DVT DEVELOPED AND IT CAN BE IMPLIED MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE COMPLICATION. 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 THAT THE PATIENT SUFFERED FROM ACUTE RIGHT FEMORAL VEIN DEEP VEIN THROMBOSIS WHILE IN THE HOSPITAL POST RIGHT TOTAL HIP ARTHROPLASTY. DEVICE REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064003 LINER NEUTRAL 36 MM I.D. SIZE F FOR USE WITH G7 ACETABULAR SYSTEM ONLY PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64319477

    Patients

    Seq Age Sex Outcome Treatment
    1 Other