BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 48ODX42ID

    MDR report key: 3921535 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-06000
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    March 13, 2008
    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

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

    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: 4. LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY. 8. DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2008 DUE TO A LOOSE ACETABULAR COMPONENT AND MULTIPLE DISLOCATIONS. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT THE ACETABULAR CUP WAS REMOVED AND REPLACED DURING THE REVISION SURGERY.

    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 WAS REVISED ON (B)(6) 2008 DUE TO A LOOSE ACETABULAR COMPONENT AND MULTIPLE DISLOCATIONS. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT THE ACETABULAR CUP WAS REMOVED AND REPLACED DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401178 M2A-MAGNUM PF CUP 48ODX42ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 002110

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R