BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS OPEN INTL FEM RT 70

    MDR report key: 6323697 · Received February 10, 2017

    Report

    Report Number
    0001825034-2017-00594
    Event Type
    Injury
    Date Received
    February 10, 2017
    Report Date
    December 21, 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
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PATIENT WEIGHT - NI, UNIQUE IDENTIFIER (UDI) # - NA, DATE EXPLANTED - NI, THERAPY DATES - NI. CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: BMET ARCOM AP PAT 3PST 34 MM MD, ITEM NUMBER: 11-150842, LOT NUMBER: 640760. ITEM NAME: BIOMET CC I-BEAM TRAY 75 MM , ITEM NUMBER: 141224, LOT NUMBER: 065330. ITEM NAME: VNGD PS TIB BRG 10 X 71/75 MM , ITEM NUMBER: 183640, LOT NUMBER: 223930. ITEM NAME: OSCILLATING SAW BLADE STRYKERÂ, ITEM NUMBER: 506096, LOT NUMBER: 99X270. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2017-00595 / 00596 / 00597).

    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 RELEVANT 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. 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

    LEGAL COUNSEL FOR PATIENT WHO UNDERWENT A TOTAL KNEE ARTHROPLASTY APPROXIMATELY SEVEN YEARS AGO REPORTED PATIENT ALLEGATIONS OF REVISION SURGERY. THERE IS NO NONE REPORT THAT THE REVISION SURGERY HAS OCCURRED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106909 VANGUARD PS OPEN INTL FEM RT 70 PROTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 571030 

    Patients

    Seq Age Sex Outcome Treatment
    1 Other