BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SCREW 6.5MM X 35MM

    MDR report key: 5975169 · Received September 23, 2016

    Report

    Report Number
    0001825034-2016-03784
    Event Type
    Injury
    Date Received
    September 23, 2016
    Date of Event
    September 2, 2015
    Report Date
    August 24, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. STERILE EXPIRATION - NI. MANUFACTURING DATE - NI. THREE MEDWATCHES ARE BEING SUBMITTED FOR THIS EVENT, AS IT IS UNKNOWN WHICH SCREW WAS FOUND TO BE FRACTURED. (REFERENCE 1825034-02439, 03783 / 03784). THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2015-02218 / 02219 & 2016-01281, 02439, 03783 / 03784).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT PRODUCTS: BIOMET G7 ACETABULAR LINER CATALOG#: 010000867 LOT#: 3321534. BIOMET BIOLOXDELTA FEMORAL HEAD CATALOG#: 650-1058 LOT#: 240670. BIOMET CERAMIC TAPER ADAPTER CATALOG#: 650-1068 LOT#: 816410.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY FOUR MONTHS POST-IMPLANTATION DUE TO PAIN AND MIGRATION OF ACETABULAR COMPONENT. DURING THE PROCEDURE, METALLIC STAINED TISSUE, SCAR TISSUE, SEROUS FLUID, FRACTURED SCREW, LOOSE BONE FRAGMENTS, BONE DAMAGE, TIGHTENING OF THE HIP WITH PROTRUSION AND IMPINGEMENT WERE NOTED. THE MODULAR HEAD, CUP AND LINER WERE REMOVED AND REPLACED WITH LEGACY ZIMMER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624003 G7 SCREW 6.5MM X 35MM PROSTHESIS, HIP PBI BIOMET ORTHOPEDICS N/A 3338824

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R