BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET KNEE SYSTEM FIXED CRUCIATE TIBIAL PLATE INTERLOK ¿ WITH LOCKING BAR

    MDR report key: 6137815 · Received December 1, 2016

    Report

    Report Number
    0001825034-2016-04961
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    September 7, 2016
    Report Date
    March 31, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. (B)(4). CONCOMITANT MEDICAL PRODUCTS - VANGUARD FEMUR CATALOG 183030 LOT J3792462; SERIES A PATELLA CATALOG 184700 LOT 901770; VANGUARD ANTERIOR STABILIZED TIBIAL BEARING CATALOG 189102 LOT 477990. 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." NUMBER 15 STATES, "INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CT SIGMA TOTAL KNEE ARTHROPLASTY GUIDE SET 03-05 CATALOG # 42-422556 LOT # 159000. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF RETURNED PARTS IDENTIFIED SCRATCHES ON THE LOCKING BAR LIKELY CAUSED BY INSERTION AND REMOVAL OF THE LOCKING BAR AND A CLOSER LOOK AT THE HOOK ON THE LOCKING BAR DID NOT IDENTIFY ANY WEAR OR MARKINGS TYPICALLY FOUND WHEN IT IS WELL FIXED. REVIEW OF THE PROVIDED X-RAY CONFIRMS THE COMPLAINT REPORT AS THE LOCKING BAR IS DISASSOCIATED FROM THE TRAY. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY SIX WEEKS POST IMPLANTATION DUE TO THE LOCKING BAR BACKING OUT OF THE TIBIAL TRAY, WHICH ALSO CAUSED PAIN. THE TIBIAL BEARING AND LOCKING BAR WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789369 BIOMET KNEE SYSTEM FIXED CRUCIATE TIBIAL PLATE INTERLOK ¿ WITH LOCKING BAR PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A J3790917

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R