BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO FX 7MM STD FEMORAL

    MDR report key: 8947397 · Received August 29, 2019

    Report

    Report Number
    0001825034-2019-03875
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    August 26, 2019
    Report Date
    December 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K063614
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 139247 ENDO II TAPER INSERT STD 0MM T LOT#: 596440, CATALOG#: 162656 INGL ANSR IMPCT DSTL PSTNR 9 LOT#: 648390, CATALOG#: 12-139016 ENDO II MOD ENDO HEAD SZ 46 LOT#: 805270. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP REVISION DUE TO FAILED CEMENT MANTEL POST IMPLANTATION. 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
    739831 ECHO FX 7MM STD FEMORAL PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 678660

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R