BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC TYPE1 BM

    MDR report key: 8129822 · Received December 4, 2018

    Report

    Report Number
    0001825034-2018-11026
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    February 2, 2018
    Report Date
    August 2, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K101086. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- G7 BONEMASTER LTD ACETABULAR SHELL # ITEM 010000702 LOT 3763297, G7 HI-WALL E1 LINER # ITEM 010000934 LOT 3877927, DELTA CERAMIC FEM HEAD # ITEM 650-0661 LOT 2016110483. (B)(6). 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 TENDERNESS IN THE GREATER TROCHANTER APPROXIMATELY ONE YEAR POST INITIAL HIP SURGERY. THE PATIENT WAS ADMINISTERED STEROID INJECTION GUIDED BY ULTRASOUNDS, WHICH HAS RELIEVED HER PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969643 TAPERLOC TYPE1 BM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 2496285

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention