BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL HEXLOC SHELL 52MM B

    MDR report key: 2500783 · Received March 22, 2012

    Report

    Report Number
    0001825034-2012-00310
    Event Type
    Injury
    Date Received
    March 22, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 24, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK861433
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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. DATE IMPLANTED - 1994; EXACT DATE UNKNOWN. 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 1825034-2012-00311).

    Additional Manufacturer Narrative · 1

    THE OUTER DIMENSION OF THE MODULAR SHELL SHOWS AREAS WHERE THE ROUGHENED SURFACE HAS BEEN MARRED. SMALL PATCHES OF BONE ARE STILL EVIDENT ON THE SHELL, INDICATING FIXATION. THE MARRED SECTIONS OF THE SHELL MAY HAVE OCCURRED DURING REMOVAL.THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00310-1 / 00311-1).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY IN 1994. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2012. THE SURGEON NOTED WEAR OF THE ACETABULAR LINER. THE ACETABULAR CUP, LINER AND MODULAR HEAD WERE REMOVED AND REPLACED. ONLY THE CUP AND LINER WERE MANUFACTURED BY BIOMET ORTHOPEDICS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL HEXLOC SHELL 52MM B PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 680110

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R