BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERF CONS TIB INLAY 15MM S

    MDR report key: 3041938 · Received April 9, 2013

    Report

    Report Number
    0009610576-2013-00009
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    JWH
    PMA / PMN Number
    PK936274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. ITEM HAS NOT BEEN RETURNED TO THE MANUFACTURER. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY KNEE SURGERY ON AN UNKNOWN DATE. REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE DUE TO LOOSENING OF THE TIBIAL SCREW. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145645 PERF CONS TIB INLAY 15MM S PROSTHESIS, KNEE JWH BIOMET SPAIN, S.L. N/A 0000567097

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R