BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/M2A MAGNUM MODULAR HEAD 40MM HEAD DIAMETER

    MDR report key: 6072583 · Received November 2, 2016

    Report

    Report Number
    0001825034-2016-03986
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    January 18, 2014
    Report Date
    October 4, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03984 / 03986).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: BIOMET E-POLY ACETABULAR LINER: CATALOG#: EP-108424, LOT#: 389180. BIOMET SCREW: CATALOG#: 103535, LOT#: 470330. BIOMET SCREW: CATALOG#: 103534, LOT#: 863960. BIOMET SCREW: CATALOG#: 103533, LOT#: 745740. BIOMET MALLORY HEAD FEMORAL STEM: CATALOG#: CP154576, LOT#: 553430.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY TWELVE MONTHS POST-IMPLANTATION DUE TO INSTABILITY. THE HEAD AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723108 SELEX/M2A MAGNUM MODULAR HEAD 40MM HEAD DIAMETER PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 786910

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R