BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET FIXED CRUCIATE TIBIAL PLATE INTERLOK - WITH LOCKING BAR

    MDR report key: 7415334 · Received April 10, 2018

    Report

    Report Number
    0001825034-2018-02481
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    March 13, 2018
    Report Date
    May 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN VANGUARD FEMORAL COMPONENT CATALOG # UNKNOWN LOT # UNKNOWN, UNKNOWN VANGUARD ARTICULAR SURFACE CATALOG # UNKNOWN LOT # UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT IS NOT BEING RETURNED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2018-02482, 0001825034-2018-02483. PRODUCT NOT RETURNED BY HOSPITAL.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: N PS CLSD INTLK FEM-RT 65 CAT: 183208 LOT: 593230. VNGD PS+ TIB BRG 12X63/67MM CAT: 183722 LOT: 749490. SERIES A PAT STD 34 3 PEG CAT: 184766 LOT: 918900. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253372 BIOMET FIXED CRUCIATE TIBIAL PLATE INTERLOK - WITH LOCKING BAR PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A J3942087

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R