BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 54F

    MDR report key: 3952353 · Received July 23, 2014

    Report

    Report Number
    0001825034-2014-06398
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    August 21, 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
    MT, 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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS CONFIRMED THE PLASTIC LINERS HAVE CHANGED DIMENSIONALLY (AS RECEIVED BY BIOMET), BUT IT IS IMPOSSIBLE TO DETERMINE THE CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6), 2014. DURING THE PROCEDURE, THE LINER WOULD NOT LOCK INTO THE ACETABULAR CUP. A SECOND LINER WAS ATTEMPTED UNSUCCESSFULLY. THE ACETABULAR CUP WAS REMOVED AND ANOTHER ACETABULAR CUP WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430582 G7 PPS LTD ACET SHELL 54F PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 3087646

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention