BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 ACETABULAR SHELL 3 HOLE POROUS PLASMA, CEMENTLESS 50MM D

    MDR report key: 6015547 · Received October 10, 2016

    Report

    Report Number
    0001825034-2016-04048
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    January 19, 2016
    Report Date
    October 6, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. AN EVALUATION WILL NOT BE COMPLETED, AS THE PACKAGING MATERIALS FOR THE DEVICE WERE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL TOTAL HIP ARTHROPLASTY, WHEN THE OUTER PACKAGING OF THE ACETABULAR CUP WAS OPENED, IT WAS DISCOVERED THE VACUUM SEALED POUCH WAS NO LONGER SEALED. IT WAS FURTHER REPORTED THAT THE IMPLANT HAD ABRASED THE POUCH, COMPROMISING THE VACUUM SEAL. ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665434 G7 ACETABULAR SHELL 3 HOLE POROUS PLASMA, CEMENTLESS 50MM D PROSTHESIS, HIP PBI BIOMET ORTHOPEDICS N/A 3385780

    Patients

    Seq Age Sex Outcome Treatment
    1