BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY-HEAD SHORT FEMORAL STEM

    MDR report key: 6751371 · Received July 28, 2017

    Report

    Report Number
    3002806535-2017-00619
    Event Type
    Injury
    Date Received
    July 28, 2017
    Report Date
    January 25, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    MEH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K021403. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM CUSTOMER. 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 THAT DURING AN INITIAL TOTAL HIP ARTHROPLASTY PROCEDURE, THE PATIENT'S CALCAR FRACTURED DURING IMPLANT OF THE DEFINITIVE STEM. CABLES WERE USED TO FIX THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531817 MALLORY-HEAD SHORT FEMORAL STEM PROSTHESIS, HIP MEH BIOMET UK LTD. N/A 3371045

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention