BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS TIBIAL BEARING 12X87/91

    MDR report key: 3182958 · Received June 21, 2013

    Report

    Report Number
    0001825034-2013-02140
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. EVALUATION INDICATES ROOT CAUSE OF FRACTURE WAS DUE TO REPEATED HYPEREXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (B)(6) 2008. SUBSEQUENTLY THE POSTERIOR STABILIZED POST BROKE OFF OF THE TIBIAL POLYETHYLENE COMPONENT. LOOSE BODY WAS REMOVED ARTHROSCOPICALLY ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283596 VANGUARD PS TIBIAL BEARING 12X87/91 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 217960

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R