BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM TIBIAL BEARING 10X71/75MM

    MDR report key: 3050653 · Received April 10, 2013

    Report

    Report Number
    0001825034-2013-00906
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. LOT NUMBER & EXPIRY DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. MANUFACTURE DATE - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE 17 YEARS AGO. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013, DUE TO INSTABILITY, SWELLING AND PAIN. POLYETHYLENE WEAR WAS NOTED DURING THE SURGERY AND THE BEARING WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152053 MAXIM TIBIAL BEARING 10X71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R