BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-RLOC LNR STD SZ 24/28MM

    MDR report key: 3180054 · Received June 20, 2013

    Report

    Report Number
    0001825034-2013-02058
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    October 6, 2001
    Report Date
    May 28, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK002379
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 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 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS. NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." AND NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 1 OF 8 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02058 / 02065). 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 ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2001. SUBSEQUENTLY, PATIENT ALLEGES PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, FRACTURES, METALLOSIS, ELEVATED METAL ION LEVELS AND DISLOCATION. A REVIEW OF INVOICE HISTORY CONFIRMS REVISION PROCEDURE WERE PERFORMED ON THE (B)(6) 2001. OTHER REVISION PROCEDURES WERE PERFORMED (B)(6) 2003 AND (B)(6) 2008 DUE TO UNKNOWN REASONS. REVIEW OF INVOICE HISTORY FOUND PATIENT UNDERWENT PROCEDURE (B)(6) 2010 IN WHICH CABLE SYSTEM WAS USED. LEGAL COUNSEL ALLEGES A REVISION PROCEDURE WAS PERFORMED (B)(6) 2003, HOWEVER; NO INVOICE HISTORY COULD BE FOUND AND CANNOT BE CONFIRMED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2001. PATIENT¿S LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, FRACTURES, METALLOSIS, ELEVATED METAL ION LEVELS AND DISLOCATION AND THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2003. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. A REVIEW OF INVOICE HISTORY CONFIRMS THE PRIMARY SURGERY DATE AND THAT REVISION PROCEDURES WERE PERFORMED ON THE FOLLOWING DATES: (B)(6) 2001, (B)(6) 2003, (B)(6) 2007, (B)(6) 2008 AND (B)(6) 2010. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS CONFIRMS THE REVISION PROCEDURES FOR ALL OF THE ABOVE MENTIONED DATES WERE PERFORMED DUE TO RECURRENT DISLOCATIONS AS A RESULT OF PATIENT NON-COMPLIANCE. PATIENT MEDICAL RECORDS FURTHER INDICATE THE FOLLOWING: (B)(6) 2002 ¿ REVISION DUE TO DISLOCATION WHERE ALL COMPONENTS EXCEPT THE FEMORAL STEM WERE REMOVED AND REPLACED. (B)(6) 2003 ¿ REVISION DUE TO DISLOCATION WHERE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED (B)(6) 2003 ¿ REVISION DUE TO DISLOCATION WHERE ALL COMPONENTS EXCEPT THE FEMORAL STEM WERE REMOVED AND REPLACED. (B)(6) 2007 ¿ REVISION DUE TO DISLOCATION AFTER AUTO ACCIDENT WHERE ALL COMPONENTS EXCEPT THE FEMORAL STEM WERE REMOVED AND REPLACED (B)(6) 2008 ¿ REVISION DUE TO DISLOCATION WHERE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED (B)(6) 2010 ¿ REVISION DUE TO DISLOCATION WHERE ALL COMPONENTS WERE REMOVED AND A GIRDLESTONE PROCEDURE WAS PERFORMED. BIOMET CABLE AND PLATE SYSTEM WERE IMPLANTED DUE TO FRACTURE OF THE GREATER TROCHANTER DURING THE PROCEDURE. (B)(6) 2010 - IRRIGATION AND DEBRIDEMENT PROCEDURE OCCURRED DUE TO INFECTION. THE BIOMET CABLE AND PLATE SYSTEM WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280729 M2A-RLOC LNR STD SZ 24/28MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 069970

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R