BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD+6MM NK NO SKRT

    MDR report key: 3971544 · Received July 31, 2014

    Report

    Report Number
    0001825034-2014-06628
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    December 30, 2003
    Report Date
    February 17, 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

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06628 AND 2015-00845 / 00846).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2005 DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, AND ELEVATED METAL ION LEVELS. 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 TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2005 DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, AND ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM OPERATIVE REPORT NOTED PATIENT UNDERWENT A BILATERAL HEMIARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED TO A RIGHT TOTAL HIP SYSTEM ON (B)(6) 2002 DUE TO PAIN. OPERATIVE REPORT NOTED PATIENT UNDERWENT A SECOND REVISION PROCEDURE ON (B)(6) 2003 DUE TO INSTABILITY AND SUBLUXATION. THE REVISION OPERATIVE REPORT NOTED THE PRESENCE OF SEROUS FLUID, WOUND DEHISCENCE, TORN AND RUPTURED SUTURES, AND SCORE MARKS ON THE HEAD. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A COMPETITOR CUP AND A BIOMET HEAD. OPERATIVE REPORT NOTED PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2005 DUE TO PAIN AND DISLOCATION. THE REVISION OPERATIVE REPORT NOTED THE PRESENCE OF FULL-THICKNESS FASCIAL DEFECT, CLEAR FLUID, LACK OF HEALING IN THE ANTERIOR ABDUCTORS, POSTERIOR CAPSULE AND PSEUDOCAPSULE. THE BIOMET MODULAR HEAD AND COMPETITOR CUP WERE REMOVED AND REPLACED WITH A BIOMET HEAD AND COMPETITOR CUP. OPERATIVE REPORT FURTHER NOTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2007 DUE TO INFECTION. THE REVISION OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF GRANULATION TISSUE AND INFECTED SYNOVIAL TISSUE. ALL COMPONENTS WERE REMOVED AND CEMENT SPACER MOLDS WERE IMPLANTED. PATIENT WAS REIMPLANTED (B)(6) 2007 WITH COMPETITOR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447787 M2A 38MM MOD HD+6MM NK NO SKRT PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 166040

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R