BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISH FINNED TIBIAL TRAY 71MM

    MDR report key: 2991351 · Received March 6, 2013

    Report

    Report Number
    0009610576-2013-00004
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. MANUFACTURING HISTORY HAS BEEN REVIEWED WITH ITEMS SHOWING NO NON-CONFORMITY, REJECTION OR CONCESSION IN ANY STAGE OF THE MANUFACTURING PROCESS. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FROM THIS LOT. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY TOTAL KNEE REPLACEMENT ON (B)(6) 2011. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013, DUE TO PATIENT FALLING AND FRACTURING THE TIBIA. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96211 POLISH FINNED TIBIAL TRAY 71MM FINNED ONE-PIECE TIBIAL TRAY JWH BIOMET SPAIN, S.L. N/A 2011070541

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R