BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS+ TIBIAL BEARING

    MDR report key: 7415361 · Received April 10, 2018

    Report

    Report Number
    0001825034-2018-02482
    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
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTA: N PS CLSD INTLK FEM-RT 65 CAT: 183208 LOT: 593230. BIOMET CC CRUCIATE TRAY 67MM CAT: 141232 LOT: J3942087. 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 RELEVANT TO THE REPORTED EVENT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: UNKNOWN VANGUARD FEMORAL COMPONENT CATALOG # UNKNOWN LOT # UNKNOWN. UNKNOWN VANGUARD TIBIAL COMPONENT 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: 0001825034-2018-02481. 0001825034-2018-02483. PRODUCT NOT RETURNED BY HOSPITAL.

    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
    253398 VANGUARD PS+ TIBIAL BEARING PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 749490

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R