BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISH FINNED TIBIAL TRAY 79MM

    MDR report key: 3140361 · Received May 31, 2013

    Report

    Report Number
    0009610576-2013-00013
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    March 24, 2013
    Report Date
    May 2, 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. 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. EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE - 2012 (EXACT DATE UNKNOWN).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY KNEE SURGERY ON (B)(6) 2013. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242149 POLISH FINNED TIBIAL TRAY 79MM FINNED ONE-PIECE TIBIAL TRAY JWH BIOMET SPAIN, S.L. N/A 2012102727

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R