BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD+6MM NK NO SKRT

    MDR report key: 3171051 · Received June 14, 2013

    Report

    Report Number
    0001825034-2013-01971
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    February 17, 2004
    Report Date
    April 13, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01970 / 01971).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2004, DUE TO PATIENT ALLEGATIONS OF METAL POISONING, METALLOSIS, PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND LACK OF MOBILITY. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2004 DUE TO PATIENT ALLEGATIONS OF METAL POISONING, METALLOSIS, PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND LACK OF MOBILITY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6) 2004. OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF CLEAR JOINT FLUID DURING THE PROCEDURE. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED AND A LINER WAS IMPLANTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270756 M2A 38MM MODULAR HEAD+6MM NK NO SKRT PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 278440

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R