BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 50ODX44ID

    MDR report key: 3912769 · Received July 3, 2014

    Report

    Report Number
    0001825034-2014-05936
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    September 17, 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

    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 UNDER POSSIBLE ADVERSE EFFECTS: 8. DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05936 / 05937).

    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.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: EVENT DESCRIPTION ¿ PATIENT WAS NOT ENROLLED IN A CLINICAL STUDY. A RETROSPECTIVE CLINICAL REVIEW IDENTIFIED THE PATIENT¿S EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, PATIENT EXPERIENCED DISLOCATIONS DUE TO BENDING OVER AND UNDERWENT CLOSED REDUCTIONS. NO REVISION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED NOTED PATIENT EXPERIENCED A WOUND DEHISCENCE WITHOUT INFECTION SIX WEEKS POST OPERATIVE.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, THE PATIENT EXPERIENCED DISLOCATIONS DUE TO BENDING OVER AND UNDERWENT CLOSED REDUCTIONS; AND EXPERIENCED A WOUND DEHISCENCE WITHOUT INFECTION SIX WEEKS POST OPERATIVE. NO REVISION HAS BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, PATIENT EXPERIENCED DISLOCATIONS DUE TO BENDING OVER AND UNDERWENT CLOSED REDUCTIONS. NO REVISION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390373 M2A-MAGNUM PF CUP 50ODX44ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 762870

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization