BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM - E1 VNGD AS TIB BRG 10X75

    MDR report key: 6572494 · Received May 17, 2017

    Report

    Report Number
    0001825034-2017-03325
    Event Type
    Injury
    Date Received
    May 17, 2017
    Date of Event
    February 23, 2015
    Report Date
    August 2, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL 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. DEVICE HISTORY RECORD (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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - VANGUARD FEMUR CATALOG #: 183066 LOT #: 999420; REGENEREX TIBIAL TRAY CATALOG #: 141274 LOT #: 866350; MODULAR SPLINED STEM CATALOG #: 141369 LOT # 069890; AND REGENEREX PATELLA CATALOG #: 141357 LOT # 003840.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO INSTABILITY AND LAXITY; THE TIBIAL BEARING AND LOCKING BAR WERE EXCHANGED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. OPERATIVE NOTES PROVIDED NOTED THAT THE KNEE DISPLAYED INSTABILITY WITH VARUS AND VALGUS STRESSING BUT WAS TIGHT IN FLEXION. A HYPERTROPHIC FAT PAD WAS ALSO NOTED, THIS WAS REMOVED AND A LATERAL RETINACULAR RELEASE WAS ALSO PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354147 VANGUARD COMPLETE KNEE SYSTEM - E1 VNGD AS TIB BRG 10X75 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 026810

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R