BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PRI-LIP TIBIAL BEARING 12X71/75

    MDR report key: 3910423 · Received July 2, 2014

    Report

    Report Number
    0001825034-2014-05812
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 16, 2014
    Report Date
    August 5, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05812 & 05911).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE COMPONENT SHOWED EVIDENCE OF OSTEOLYSIS AND DELAMINATION CONSISTENT WITH TIBIAL LOOSENING. BEARING DELAMINATION WAS CONSIDERED ACCEPTABLE GIVEN THE LIFETIME EXPECTATION OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE ARTHROPLASTY ON (B)(6) 2000. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO TIBIAL LOOSENING AS A RESULT OF OSTEOLYSIS. THE TIBIAL TRAY AND TIBIAL BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388636 MAX PRI-LIP TIBIAL BEARING 12X71/75 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 035180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R