BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ACETABULAR SHELL

    MDR report key: 8574827 · Received May 2, 2019

    Report

    Report Number
    0001825034-2019-02032
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    December 7, 2017
    Report Date
    June 12, 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
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    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 PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: 010000996, G7 SCREW 6.5MM X 15MM, LOT 3716839; 650-1163, DELTA CER FEM HD 32/-3MM, LOT 2994760; 110003621, BIOLOX DELTA CER LNR 32MM, LOT 3650144; ITEM NUMBER: 192109, ITEM NAME: ECHO FEMORAL STEM, LOT #: 944610. FOREIGN REPORT SOURCE: (B)(6). REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 UNDERWENT RIGHT HIP REVISION APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO PERIPROSTHETIC FRACTURE. DURING THE REVISION SURGERY A HEMATOMA WAS NOTED. STEM, LINER AND HEAD COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366135 UNKNOWN ACETABULAR SHELL PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R