BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE FEMORAL STEM

    MDR report key: 7762649 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-06856
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    August 16, 2016
    Report Date
    September 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 650-1057 ¿ CER BIOLOXD OPTION HD 36MM ¿ 5771760, 650-1064 ¿ CER OPTION TYPE 1 TPR SLEVE -6 - 9753310. THERAPY DATE: (B)( 6) 2016. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED AN INTRA-OPERATIVE CALCAR FRACTURE DURING PRIMARY RIGHT TOTAL HIP ARTHROPLASTY. PROXIMAL CABLE WAS PLACED. 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
    602369 TAPERLOC COMPLETE FEMORAL STEM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3760692

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R