BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 58ODX52ID

    MDR report key: 3924445 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-05998
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 5, 2009
    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

    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 THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING.¿ THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05998 / -05999).

    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.

    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) 2007 DUE TO AVASCULAR NECROSIS, STAGE III. SUBSEQUENTLY, PATIENT EXPERIENCED THREE DISLOCATIONS TREATED BY CLOSED REDUCTION. NO REVISION HAS BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007 DUE TO AVASCULAR NECROSIS, STAGE III. SUBSEQUENTLY, PATIENT EXPERIENCED THREE DISLOCATIONS TREATED BY CLOSED REDUCTION. NO REVISION HAS BEEN REPORTED.

    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) 2007 DUE TO AVASCULAR NECROSIS, STAGE III. SUBSEQUENTLY, PATIENT EXPERIENCED THREE DISLOCATIONS TREATED BY CLOSED REDUCTION. NO REVISION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED REVEALED THAT PATIENT'S CLOSED REDUCTION PROCEDURE WAS PERFORMED ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401604 M2A-MAGNUM PF CUP 58ODX52ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 342210

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization