BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM-BEARING

    MDR report key: 6536602 · Received May 2, 2017

    Report

    Report Number
    0001825034-2017-02962
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    April 3, 2017
    Report Date
    July 29, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). MEDICAL PRODUCT-VANGUARD CR ILOK FEMORAL CATALOG# 183033 LOT# 172950, BIOMET CC CRUCIATE TRAY CATALOG# 141235 LOT# 311720, BMET ARCOM AP PATELLA CATALOG# 11-150830 LOT# 614550. CUSTOMER HAS 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR 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 PATIENT WAS REVISED DUE TO PAIN. THE BEARING WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED DUE UNKNOWN REASONS. THE BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319200 VANGUARD COMPLETE KNEE SYSTEM-BEARING PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 227710

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R SEE H10 NARRATIVE