BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 FREEDOM CONST E1 LNR 32MM C

    MDR report key: 6714112 · Received July 14, 2017

    Report

    Report Number
    0001822565-2017-04787
    Event Type
    Injury
    Date Received
    July 14, 2017
    Date of Event
    June 16, 2017
    Report Date
    November 8, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK142882
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). CONCOMITANT MEDICAL PRODUCTS: G7 OSSEOTI MULTIHOLE 48 MM C P/N 110010262 L/N 3877561, G7 SCREW 6.5 MM X 50 MM P/N 010001003 L/N 3914351, G7 SCREW 6.5 MM X 30 MM P/N 010000999 L/N 3967182. 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. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110025129 949990 FREEDOM CONSTRAINED MODULAR HEAD 32 MM/ -3 MM NECK TYPE 12/14 TAPER, UNKNOWN CUP, UNKNOWN STEM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04862.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNSTABLE AND DISLOCATING.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT'S HIP WAS REVISED APPROXIMATELY 3 WEEKS POST-IMPLANTATION DUE TO INFECTION. 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
    496590 G7 FREEDOM CONST E1 LNR 32MM C PROSTHESIS, HIP LPH ZIMMER, INC. N/A 3808611

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R