BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 4251482 · Received November 14, 2014

    Report

    Report Number
    0001825034-2014-08606
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    December 12, 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 ANOMALY OR DEVIATION. UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, BONE RESORPTION, OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-06270 / 08606).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION THAT WAS REPORTED IN ERROR ON A PREVIOUS MEDWATCH. UPON REVIEW OF COMPLAINT, IT WAS NOTED THAT THIS PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 RATHER THAN A HIP RESURFACING PROCEDURE AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. DURING POST-OPERATIVE MONITORING, A MIGRATED ACETABULAR CUP WAS NOTED. PATIENT WAS ASYMPTOMATIC ONE YEAR POST-OP, IS BEING OBSERVED AND HAS NOT BEEN REVISED TO 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) 2008. DURING POST-OPERATIVE MONITORING, A MIGRATED ACETABULAR CUP WAS NOTED. PATIENT WAS ASYMPTOMATIC ONE YEAR POST-OP, IS BEING OBSERVED AND HAS NOT BEEN REVISED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737854 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 892620

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R