BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 42MM

    MDR report key: 5736452 · Received June 20, 2016

    Report

    Report Number
    0001825034-2016-02138
    Event Type
    Injury
    Date Received
    June 20, 2016
    Date of Event
    August 18, 2014
    Report Date
    November 16, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." (B)(4). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT PRODUCTS: BIOMET M2A MAGNUM CUP CATALOG#: US157848 LOT#: 092790, BIOMET TAPERLOC STEM CATALOG#: 103201 LOT#: 340660. (B)(4). THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-02138 & 04717).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, POPPING SOUND, METAL DEBRIS, AND METALLOSIS. REVIEW OF INVOICE HISTORY CONFIRMS THE MODULAR HEAD WAS REMOVED AND REPLACED WITH A CERAMIC HEAD AND A POLY BEARING WAS IMPLANTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, POPPING SOUND, METAL DEBRIS, AND METALLOSIS. REVIEW OF INVOICE HISTORY CONFIRMS THE MODULAR HEAD WAS REMOVED AND REPLACED WITH A CERAMIC HEAD AND A POLY BEARING WAS IMPLANTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. IT WAS REPORTED IN OPERATIVE REPORT RECEIVED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO PAIN AND SWELLING. DURING THE PROCEDURE, PSEUDOTUMOR FORMATION AND METALLOSIS JOINT FLUID WERE NOTED. THE FEMORAL HEAD WAS REMOVED AND REPLACED. AN ACETABULAR BEARING WAS ALSO IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391085 M2A-MAGNUM MOD HD SZ 42MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 069140

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R