BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-TAPER LINER SZ 41/32

    MDR report key: 3943928 · Received July 18, 2014

    Report

    Report Number
    0001825034-2014-06303
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    April 15, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDL
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THESE TYPES OF EVENTS CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06303 AND 06304).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, ON (B)(6) 2014, PATIENT UNDERWENT A REVISION PROCEDURE DUE TO ALLEGED LYSIS AROUND THE CUP AND STEM. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND INDICATES ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423190 M2A-TAPER LINER SZ 41/32 PROSTHESIS, HIP JDL BIOMET ORTHOPEDICS N/A 462200

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R