BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 4 HOLE SHELL 54MM F

    MDR report key: 6595893 · Received May 26, 2017

    Report

    Report Number
    0001825034-2017-03456
    Event Type
    Injury
    Date Received
    May 26, 2017
    Date of Event
    May 3, 2017
    Report Date
    November 10, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAY ANALYSIS SHOWS THAT OVER THE TIME, LUCENCY SURROUNDING THE CUP EXTENDED FROM SUPEROMEDIAL TO THE CUP TO ILIOISCHIAL LINE. CUP LOOSENING IS LIKELY DUE TO PERIPROSTHETIC LUCENCY SURROUNDING THE CUP. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE 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). 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 WILL BE SUBMITTED. (B)(4). CONCOMITANT PRODUCTS: 110024464 G7 DUAL MOBILITY LINER 845480; EP-200150 ACT ARTIC 963330; 12-115110 BILOX HEAD 266380; 010000996 G7 SCREW 6.5MM X 15MM 3659053; 010000998 G7 SCREW 6.5MM X 25MM 3619526; 51-103110 TPRLC 133 TYPE1 PPS SO 11.0 3799236.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LEFT HIP WAS REVISED APPROXIMATELY SIX MONTHS POST-IMPLANTATION DUE TO ACETABULAR LOOSENING AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375036 G7 OSSEOTI 4 HOLE SHELL 54MM F PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 3848752

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R