BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MODULAR HEAD 40MM -6

    MDR report key: 3171043 · Received June 14, 2013

    Report

    Report Number
    0001825034-2013-01968
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    November 23, 2009
    Report Date
    January 23, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, 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." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01968 / 01969).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY FURTHER PATIENT INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01968 / 01969 AND 2014-00889 / 00892).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTS THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A REVISION PROCEDURE OCCURRED ON (B)(6)2009 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, AND ELEVATED METAL ION LEVELS. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED DURING THE REVISION PROCEDURE. 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

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE OCCURRED ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF PAIN, 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 PROVIDED IN REVISION OPERATIVE NOTES INDICATES THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2009 WAS DUE TO ACETABULAR CUP LOOSENING AND THE PRESENCE OF DARK-COLORED SYNOVIAL TISSUE CONSISTENT WITH METAL WEAR. THE ACETABULAR CUP AND MODULAR HEAD WAS REMOVED AND REPLACED. FURTHERMORE, REVISION OPERATIVE NOTES INDICATE THAT THREE SUBSEQUENT REVISION PROCEDURES OCCURRED DUE TO INSTABILITY. A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2009 TO REMOVE AND REPLACE THE ACETABULAR LINER. A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2010 TO REMOVE AND REPLACE THE ACETABULAR LINER WITH A CONSTRAINED LINER. A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2010 TO REMOVE AND REPLACE THE CONSTRAINED LINER WITH A TRI-POLAR SYSTEM. IN ADDITION, REVISION OPERATIVE NOTES PROVIDED INDICATE THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 TO REMOVE AND REPLACE THE ACETABULAR LINER. OPERATIVE NOTES FOR THIS REVISION PROCEDURE FURTHER INDICATE THAT A SYNOVECTOMY WAS PERFORMED AND THAT THE SURGEON NOTED POLYETHYLENE WEAR OF THE ACETABULAR LINER FROM ANTERIOR SUBLUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270588 SELEX/MAGNUM MODULAR HEAD 40MM -6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 254800

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R