BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PS DCM TIB BRNG 10X71/75MM

    MDR report key: 3964933 · Received July 29, 2014

    Report

    Report Number
    0001825034-2014-06502
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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: PRODUCT IDENTIFICATION/EXPIRATION DATE - UNKNOWN; DATE IMPLANTED - SOMETIME DURING 2012; INITIAL REPORTER - UNKNOWN; PMA/510(K) NUMBER; MANUFACTURE DATE ¿ UNKNOWN. DEVICE STILL IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY INITIAL PROCEDURE DATE AND PRODUCT IDENTIFICATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO LOOSENING OF AN UNKNOWN COMPONENT; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2012. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO LOOSENING OF AN UNKNOWN COMPONENT. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2012. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO LOOSENING OF AN UNKNOWN COMPONENT; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440988 MAX PS DCM TIB BRNG 10X71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 021650

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention