BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP INLK PRI TIB TRAY 73MM

    MDR report key: 5871597 · Received August 12, 2016

    Report

    Report Number
    0001825034-2016-03078
    Event Type
    Injury
    Date Received
    August 12, 2016
    Date of Event
    July 11, 2016
    Report Date
    March 10, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 THE 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 4 STATES, "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION AND/OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY AND/OR EXCESSIVE WEIGHT." DEVICE REQUESTED, NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THIS REPORT IS ASSOCIATED WITH (B)(4). UDI # (B)(4). CONCOMITANT MEDICAL PRODUCTS: PATELLA - CATALOGUE: 184764 LOT: 143260, FEMUR - CATALOGUE: 195921 LOT: 743030, LEFT LATERAL TIBIAL BEARING - CATALOGUE: 195814 LOT 126870, LEFT MEDIAL TIBIAL BEARING - CATALOGUE: 195884 LOT 710450. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL INSPECTION OF THE COMPLAINT PRODUCT, THE TIBIAL TRAY SHOWS A SUBSTANTIAL AMOUNT OF BONE CEMENT ADHERED TO THE INFERIOR PORTION OF THE TRAY WHICH INDICATES PROPER FIXATION OF IMPLANT TO CEMENT. DIMENSIONAL ANALYSIS OF THE TIBIAL TRAY SHOWS THE UNIT WAS MANUFACTURED TO PRINT AND SPECIFICATIONS. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. (B)(6).

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A KNEE REVISION DUE TO TIBIAL LOOSENING. THE TIBIAL TRAY, TIBIAL BEARINGS AND LOCKING BAR WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524917 VGXP XP INLK PRI TIB TRAY 73MM PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 916870

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R