BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 50ODX44ID

    MDR report key: 3941163 · Received July 17, 2014

    Report

    Report Number
    0001825034-2014-06197
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    January 23, 2012
    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

    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, NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING."

    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

    EVENT DESCRIPTION ¿ PATIENT WAS NOT ENROLLED IN A CLINICAL STUDY. A RETROSPECTIVE CLINICAL REVIEW IDENTIFIED THE PATIENT¿S EVENT. UPDATE TO CONCLUSION: 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: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY.¿

    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) 2009. DURING POST-OPERATIVE MONITORING, LOOSENING OF THE ACETABULAR CUP WAS NOTED ON AU(B)(6) 2011. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2012 DUE TO THE ACETABULAR LOOSENING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2009. DURING POST-OPERATIVE MONITORING, LOOSENING OF THE ACETABULAR CUP WAS NOTED ON (B)(6) 2011. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP MONITORING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATE.

    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) 2009. DURING POST-OPERATIVE MONITORING, LOOSENING OF THE ACETABULAR CUP WAS NOTED ON (B)(6) 2011. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP MONITORING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419430 M2A-MAGNUM PF CUP 50ODX44ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 768000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R