BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR FEMORAL INTERLOK

    MDR report key: 6988556 · Received October 30, 2017

    Report

    Report Number
    0001825034-2017-09719
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    October 2, 2017
    Report Date
    November 1, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES - BIOMET INTERLOK FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR # 141233 LOT # 565810. VANGUARD CR LIPPID TIBIAL BEARING # 183540 LOT # 365160. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-09721 AND 0001825034-2017-09722 CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THEY REMAIN IMPLANTED . THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT AND SHOULD NOT HAVE BEEN REPORTED. THE INITIAL REPORT SHOULD BE VOIDED AS IT WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PATELLAR RESURFACING 10 YEARS POST INITIAL SURGERY DUE TO UNKNOWN ISSUES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767493 VANGUARD CR FEMORAL INTERLOK PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 042170

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R