BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3

    MDR report key: 2521445 · Received April 6, 2012

    Report

    Report Number
    0001825034-2012-00404
    Event Type
    Injury
    Date Received
    April 6, 2012
    Date of Event
    January 14, 2009
    Report Date
    March 8, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER FOURTEEN STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THE PRODUCT AND LOT IDENTIFICATION NUMBERS NECESSARY TO REVIEW MANUFACTURING HISTORY RECORDS WERE NOT PROVIDED. DATE OF EVENT - REVISION PROCEDURES WERE PERFORMED ON (B)(6) 2009, (B)(6) 2010, AND (B)(6) 2012. THIS REPORT IS NUMBER 3 OF 6 MDRS FILED FOR THE SAME EVENTS (REFERENCE 1825034-2012-00395 / 00396 AND 1825034-2012-00404/00407).

    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 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS NUMBER 3 OF 6 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2012-00395-1 / 00396-1 & 00404-1/00407-1).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2009, DUE TO ASEPTIC LOOSENING OF THE ACETABULAR CUP AND PAIN. THE ACETABULAR CUP, TAPER ADAPTER, AND MODULAR HEAD WERE REMOVED AND REPLACED WITH A COMPETITOR'S CUP AND ACETABULAR LINER AND A BIOMET MODULAR HEAD. PATIENT UNDERWENT A SECOND REVISION DUE TO PAIN AND ASEPTIC LOOSENING ON (B)(6) 2010. THE BIOMET MODULAR HEAD AND COMPETITOR'S CUP AND HEAD WERE REMOVED AND REPLACED. A THIRD REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012, DUE TO ASEPTIC LOOSENING AND PAIN. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM 42-50MM TPR INSRT-3 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 786060

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R