BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MODULAR HEAD 40MM -3

    MDR report key: 5941169 · Received September 9, 2016

    Report

    Report Number
    0001825034-2016-03587
    Event Type
    Injury
    Date Received
    September 9, 2016
    Date of Event
    August 26, 2015
    Report Date
    August 12, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    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 THE LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT/PATIENT (REFERENCE 1825034-2016-03573 / 03587).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION AND CORRECTED INFORMATION. CONCOMITANT MEDICAL PRODUCTS - BIOMET TAPERLOC FEMORAL STEM CATALOG#: 103200 LOT#: 884400.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION CLAIMING THE REVISING SURGEON NOTED METAL DEBRIS AND METALLOSIS DURING THE PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. PATIENT OPERATIVE REPORTS INDICATE CHRONIC PERIPROSTHETIC INFECTION AS WELL AS REACTION TO METAL ON METAL PROSTHESIS AS REASON FOR REVISION. PAIN AND AN ACETABULAR DEFECT WERE NOTED. THE PATIENT UNDERWENT AND IRRIGATION AND DEBRIDEMENT PROCEDURE AND THE COMPONENTS WERE REPLACED WITH ANTIBIOTIC CEMENT SPACERS FOR THE FIRST OF A TWO STAGE REVISION PROCEDURE.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION CLAIMING THE REVISING SURGEON NOTED METAL DEBRIS AND METALLOSIS DURING THE PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. PATIENT OPERATIVE REPORTS INDICATE CHRONIC PERIPROSTHETIC INFECTION AS WELL AS REACTION TO METAL ON METAL PROSTHESIS AS REASON FOR REVISION. PAIN AND AN ACETABULAR DEFECT WERE NOTED. THE PATIENT UNDERWENT AND IRRIGATION AND DEBRIDEMENT PROCEDURE AND THE COMPONENTS WERE REPLACED WITH ANTIBIOTIC CEMENT SPACERS FOR THE FIRST OF A TWO STAGE REVISION PROCEDURE. THE PATIENT UNDERWENT A PREVIOUS PROCEDURE TO WASHOUT THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590392 SELEX/MAGNUM MODULAR HEAD 40MM -3 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 198720

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R