BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTRAINED MODULAR HEAD 32MM/ -3MM NECK TYPE 12/14 TAPER

    MDR report key: 6706731 · Received July 12, 2017

    Report

    Report Number
    0001825034-2017-04862
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    June 16, 2017
    Report Date
    November 8, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    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

    MEDICAL DEVICES: G7 OSSEOTI MULTIHOLE 48MM C P/N 110010262 L/N 3877561; G7 SCREW 6.5MM X 50MM P/N 010001003 L/N 3914351; G7 SCREW 6.5MM X 30MM 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 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 PRODUCTS: 010000981 3808611 G7 FREEDOM CONST E1 LNR 32MM; 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: 0001822565-2017-04787.

    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
    488697 FREEDOM CONSTRAINED MODULAR HEAD 32MM/ -3MM NECK TYPE 12/14 TAPER PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 949990

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R