BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 3800640 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03739
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 9, 2014
    Report Date
    October 2, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED PRODUCT IDENTIFICATION.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION.

    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, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03738 / 03740).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL/CORRECTED INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2011 DUE TO PAIN. ON (B)(6) 2014, PATIENT UNDERWENT A SECOND REVISION PROCEDURE DUE TO DISLOCATION. THE MODULAR HEAD, LINER AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279464 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 453110

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R