BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR FEMORAL COMPONENT

    MDR report key: 6732664 · Received July 21, 2017

    Report

    Report Number
    0001825034-2017-05068
    Event Type
    Injury
    Date Received
    July 21, 2017
    Report Date
    September 23, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. RISKS ASSOCIATED WITH THE REPORTED CONDITION ARE ADDRESSED THROUGH THE WARNINGS IN THE PACKAGE INSERT AS A PART OF DESIGN CONTROL RISK MANAGEMENT. 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

    PT IDENTIFIER: - (B)(6). CONCOMITANT MEDICAL PRODUCT: REGENEREX SERIES-A PATELLA 3 PEG, CAT#: 141358 LOT#: 232630. BIOMET KNEE SYSTEM MODULAR FINNED STEM WITH SCREW, CAT#: 141314 LOT#: 584160. REGENEREX PRIMARY TIBIAL TRAY WITH LOCKING BAR, CAT#: 141275 LOT#: 220440. VANGUARD TIBIAL BEARING CR LIPPED, CAT#: EP-183560 LOT#: 964280. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05065, 0001825034-2017-05066, 0001825034-2017-05067, 0001825034-2017-05068, 0001825034-2017-05069. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS OCCASIONAL PAIN AND CRAMPING IN THE LEFT KNEE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513553 VANGUARD CR FEMORAL COMPONENT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 601330

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention