BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 50MM

    MDR report key: 3181295 · Received June 21, 2013

    Report

    Report Number
    0001825034-2013-02118
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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: "IMPLANTATION OF FOREIGN MATERIAL IN TISSUES MAY RESULT IN HISTOLOGICAL REACTIONS INVOLVING VARIOUS SIZES OF MACROPHAGES AND FIBROBLASTS... PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC AND POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID." THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00932 / 00933 AND 1825034-2013-02109 / 02118). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY BLOOD TEST RESULTS, WHICH WERE UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME PERSON(REFERENCE 1825034-2012-00932 / 00933 & 2013-02109, 02118).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6) 2012 ALLEGEDLY DUE TO PAIN AND EFFECTS OF METAL DEBRIS. A REVIEW OF INVOICE HISTORY CONFIRMED THE PRIMARY SURGERY DATES AND THAT THE MODULAR HEAD WAS REMOVED AND REPLACED DURING THE LEFT HIP REVISION PROCEDURE. THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE RIGHT HIP. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATED THAT A PSEUDOCAPSULE WAS NOTED DURING THE REVISION PROCEDURE, WHICH CAUSED IMPINGEMENT. THERE WAS NO EVIDENCE OF ADVERSE LOCAL TISSUE REACTION IDENTIFIED DURING THE REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282893 M2A-38 CUP NON FLARED SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 597190

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R