BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 58ODX52ID

    MDR report key: 3924390 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-05987
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    October 4, 2006
    Report Date
    October 18, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL/CORRECTED INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EVENT DESCRIPTION ¿ PATIENT WAS NOT ENROLLED IN A CLINICAL STUDY. A RETROSPECTIVE CLINICAL REVIEW IDENTIFIED THE PATIENT¿S EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: " "LOOSENING OR MIGRATION OF IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY. "

    Additional Manufacturer Narrative · 1

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

    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. PMA/510(K) NUMBER - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A SURGICAL COMPLICATION OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2005. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO LOOSENING.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2005. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO LOOSENING. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2006. THE ACETABULAR CUP WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401909 M2A-MAGNUM PF CUP 58ODX52ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 425180

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R