BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD(TM) CR FEMORAL 75MM RIGHT POROUS COATED/BOND COATED

    MDR report key: 6231930 · Received January 7, 2017

    Report

    Report Number
    0001825034-2017-00087
    Event Type
    Injury
    Date Received
    January 7, 2017
    Date of Event
    December 16, 2016
    Report Date
    May 5, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK033489
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: TITANIUM LOW PROFILE SCREW, CATALOG# 103534, LOT# 486030; ARCOM AP PATELLA, CATALOG #11-150830, LOT# 590460; FINNED PRIMARY STEM 40MM, CATALOG # 141314, LOT# 361320; VANGUARD CR POROUS RIGHT FEMORAL 75, CATALOG # 183054, LOT# 353240; POROUS PRIMARY TIBIAL TRAY 79MM, CATALOG# 141265, LOT# 589380. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD POSSIBLY UNDERGO A REVISION PROCEDURE DUE TO UNKNOWN REASONS. IT WAS INDICATED THAT THE FEMORAL COMPONENT WOULD BE REVISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF A TOTAL KNEE ARTHROPLASTY NINE YEARS AFTER THE INITIAL PROCEDURE DUE TO INSTABILITY. IT WAS ALSO REPORTED THAT THE PATIENT FELL AND THIS CONTRIBUTED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14827 VANGUARD(TM) CR FEMORAL 75MM RIGHT POROUS COATED/BOND COATED PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 353240 

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R