BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -3MM NK

    MDR report key: 3223775 · Received July 12, 2013

    Report

    Report Number
    0001825034-2013-02668
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    August 30, 2010
    Report Date
    April 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK01110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02668 & 04786 & 2014-02753-4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PART/ LOT INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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 THESE TYPES OF EVENTS CAN OCCUR: ¿MATERIAL SENSITIVITY REACTIONS,¿

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. BRAND NAME. EXPIRATION DATE - UNKNOWN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATH AS LIMITED INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6), 2003 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2004. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP OPEN REDUCTION INTERNAL FIXATION PROCEDURE ON (B)(6), 2003. PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6), 2003 DUE TO AN UNKNOWN REASON. PATIENT UNDERWENT ANOTHER RIGHT HIP REVISION PROCEDURE ON (B)(6), 2006 DUE TO A FRACTURED STEM. PATIENT UNDERWENT ANOTHER RIGHT HIP REVISION PROCEDURE ON (B)(6), 2007 DUE TO A LOOSENED ACETABULAR CUP. PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6), 2010 DUE TO METALLOSIS AND BONE/TISSUE DAMAGE. THE MODULAR HEAD, ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED WITH COMPETITOR CUP AND LINER AND A BIOMET HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. A SUBSEQUENT REVISION WAS PERFORMED ON (B)(6) 2010, DUE TO METALLOSIS AND BONE/TISSUE DAMAGE. A REVIEW OF INVOICE HISTORY CONFIRMS THE HEAD WAS REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324155 M2A 38MM MOD HD -3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 568250

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R