BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -3MM NK

    MDR report key: 4211787 · Received October 29, 2014

    Report

    Report Number
    0001825034-2014-08425
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    November 4, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE OF EVENT, PRODUCT / LOT CODE / EXPIRATION DATE, DATE OF IMPLANT, DATE OF EXPLANT, PMA/510(K) NUMBER, MANUFACTURE DATE.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER ¿ 11-173661; LOT NUMBER - 421500; EXPIRATION DATE - JUNE 30, 2013; DATE OF IMPLANT - (B)(6) 2003 OR (B)(6) 2004; MANUFACTURE DATE ¿ JUNE 13, 2003. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER -11-173661; LOT NUMBER - 445290; EXPIRATION DATE - DECEMBER 31, 2013; DATE OF IMPLANT - (B)(6) 2003 OR (B)(6) 2004; MANUFACTURE DATE ¿ DECEMBER 10, 2003;

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO UNKNOWN REASONS WITH COMPETITOR PRODUCT. ADDITIONAL INFORMATION RECEIVED NOTED PATIENT WAS BILATERAL AND UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003 AND (B)(6) 2004. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN SIDE ON AN UNKNOWN DATE DUE TO UNKNOWN REASONS. PATIENT WAS REVISED WITH COMPETITOR PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO UNKNOWN REASONS WITH COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692353 M2A 38MM MOD HD -3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R