BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERF CONS TIB BEARING 15MM M

    MDR report key: 2862551 · Received December 10, 2012

    Report

    Report Number
    0009610576-2012-00026
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    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. EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE - UNKNOWN. DEVICE IS EXPECTED TO BE RETURNED. UPON ITEM RETURN AND COMPLETION OF EVALUATION, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE RETURNED LOCKING SCREW AND TIBIAL INLAY WERE EVALUATED. A VISUAL INSPECTION HAS CONFIRMED THAT THE LOCKING SCREW THREAD AND THE BOTTOM AREA OF TIBIAL INLAY SHOW SEVERAL AREAS OF DAMAGE. ALSO, THE LOCKING SCREW HAS INSERTED A SMALL POLYETHYLENE PLUG IN WHICH THE THREAD WILL BE CREATED WHILE BOLTING IT TO PREVENT THE SCREW FROM BECOMING LOOSE. THE THREAD HAS BEEN CREATED IN THE POLYETHYLENE PLUG, THEREFORE, INDICATES THAT THE SCREW HAS BEEN SCREWED. NO FUNCTIONAL TEST CAN BE PERFORMED IN ORDER TO VERIFY THE ASSEMBLY BETWEEN THE INVOLVED ITEMS DUE TO THE FACT THAT THE SCREW THREAD AND THE TIBIAL INLAY ARE DAMAGED. THE MANUFACTURING ORDER AND THE INSPECTION RECORDS OF THE OTHER INVOLVED PIECES (TIBIAL TRAY, TIBIAL STEM AND FEMORAL COMPONENT) IMPLANTED TO THE PATIENT HAVE BEEN REVIEWED, AND NO RELEVANT NON-CONFORMITIES HAVE BEEN FOUND. ALTHOUGH THE CAUSE OF THIS EVENT HAS NOT BEEN IDENTIFIED, NO EVIDENCES HAVE BEEN FOUND THAT COULD RELATE THE INCIDENCE TO THE INSPECTION OR MANUFACTURING PROCESS OF THE INVOLVED PIECES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY KNEE SURGERY ON (B)(6) 2010. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO THE BEARING LOOSENING. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERF CONS TIB BEARING 15MM M PROSTHESIS, KNEE JWH BIOMET SPAIN, S.L. N/A 0000367158

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R