BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CEMENTLESS CR POROUS FEMORAL

    MDR report key: 6453584 · Received April 3, 2017

    Report

    Report Number
    0001825034-2017-02363
    Event Type
    Injury
    Date Received
    April 3, 2017
    Date of Event
    April 1, 2014
    Report Date
    April 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. REVIEW OF DEVICE HISTORY RECORD FOUND EIGHT UNITS HAD STAINS ON THE POROUS COATING . 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. 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). CONCOMITANT PRODUCTS: MAXIM BIOMET FINNED STEM 80X15 MM, CATALOG #: 141320, LOT #: 848740. BIOMET CEMENTLESS PRIMARY TIBIAL TRAYS 75MM, CATALOG #: 141264, LOT #: 982870. VANGUARD HXLPE CR LIP TIBIAL BEARING, CATALOG #: 183540, LOT # 072400. CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236630 VANGUARD CEMENTLESS CR POROUS FEMORAL PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 539360 

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R