BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 52E

    MDR report key: 3981638 · Received August 5, 2014

    Report

    Report Number
    0001825034-2014-06831
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06831 / 06832).

    Additional Manufacturer Narrative · 1

    THE RETURNED ACETABULAR SHELL INSERTER ASSEMBLY LOCATION WAS EVALUATED. DUE TO THE DAMAGE AND DEFORMATION TO THE LOCATION EDGES A DIMENSIONAL CHECK WAS UNABLE TO BE PERFORMED. THE THREADS AND THE CONCENTRICITY OF THE SQUARE FORM TO THE THREADS WERE CHECKED WITH NO ISSUES FOUND. VISUAL EXAMINATION OF THE ACETABULAR SHELL INSERTER ASSEMBLY LOCATION FOUND DAMAGE INDICATING THAT THE INSERTER HAD BEEN MISALIGNED DURING ASSEMBLY. THE DAMAGE/DEFORMATION DUE TO MISALIGNMENT CAUSED IT TO JAM AND PREVENT DISENGAGEMENT FROM THE ACETABULAR SHELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, THE INSERTER THREADS WOULD NOT DISENGAGE FROM THE ACETABULAR CUP. THE ACETABULAR CUP AND INSERTER WERE REMOVED AND ANOTHER ACETABULAR CUP AND INSERTER WERE UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457363 G7 PPS LTD ACET SHELL 52E PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 3337153

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention