BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM - PS OPEN INTL FEM RT 75

    MDR report key: 6432524 · Received March 24, 2017

    Report

    Report Number
    0001825034-2017-02066
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    July 11, 2016
    Report Date
    December 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS ¿ BIOMET CRUCIATE TRAY 83MM CATALOG 141236 LOT J3227477; BIOMET CRUCIATE TRAY 83MM CATALOG 141236 LOT J3164690; VANGUARD PS FEMUR LEFT 75MM CATALOG 183134 LOT 060840; VANGUARD PS TIBIAL BEARING 79/83MM X 10MM CATALOG EP-183660 LOT 923770; VANGUARD PS TIBIAL BEARING 79/83MM X 10MM CATALOG EP-183660 LOT 644360; SERIES A PATELLA 34MM CATALOG 184766 LOT 236760; SERIES A PATELLA 34MM CATALOG 184766 LOT 914120. CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2017-02067, 1825034-2017-02068, AND 1825034-2017-02069.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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

    REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND TO BE RELATED WITH THIS EVENT. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. SURGICAL NOTES WERE PROVIDED FOR THE REVISION SURGERY. REVIEW OF THE REVISION OPERATIVE NOTES INDICATES THAT THE SURGEON NOTED NO COMPLICATIONS. THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO PATIENT'S CONDITION AS PATIENT WAS REPORTED TO HAVE A METAL ALLERGY. 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 BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY APPROXIMATELY THREE YEARS AGO. SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO PAIN, EFFUSIONS, AND METAL ALLERGIES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTIES APPROXIMATELY THREE YEARS AGO AND WAS REVISED ON AN UNKNOWN DATE DUE TO PATIENT ALLEGATIONS OF METAL ALLERGIES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213365 VANGUARD COMPLETE KNEE SYSTEM - PS OPEN INTL FEM RT 75 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 217460

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R