BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR LAT FMRL 11X142

    MDR report key: 8164311 · Received December 14, 2018

    Report

    Report Number
    0001825034-2018-11322
    Event Type
    Injury
    Date Received
    December 14, 2018
    Date of Event
    January 25, 2017
    Report Date
    July 25, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. REVIEW OF RADIOGRAPHS INDICATE FLEXIBLE OSTEOTOMES UTILIZED ON ANTERIOR, POSTERIOR AND ALONG THE CALCAR. THEN UTILIZED OSTEOTOME OVER THE SHOULDER AND DISIMPACTED THE STEM. NOTED PERFORATION OF THE LATERAL CORTEX DISTAL TO VASTUS RIDGE. SUBVASTUS APPROACH TO LATERAL FEMUR. MADE SMALL SPLIT PROXIMAL AND BENT 3.5MM LOCKING RECON PLATE TO CONTOUR TO LATERAL FEMUR AND TROCHANTER. UTILIZED 4 LOCKING SCREWS IN GREATER TROCHANTER FOR FIRM FIXATION, 3 CABLES. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 11-163667, M2A-MAGNUM MOD HD, LOT # 042600, ITEM # 15-103686, M2A-T UNIV 2-HOLE SHL, LOT # 285850, ITEM # 15-105004, M2A-TAPER LINER, LOT # 809170.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUFFERED PERFORATION OF THE LATERAL CORTEX DISTAL TO THE VASTUS RIDGE DURING A REVISION SURGERY. THE SURGEON DECIDED TO BUTTRESS THIS WITH A TROCHANTERIC PLANT LATE IN THE CASE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004919 TAPERLOC POR LAT FMRL 11X142 HIP PROSTHESIS LPH ZIMMER BIOMET, INC. N/A 895150

    Patients

    Seq Age Sex Outcome Treatment
    1 Other