BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD FEMORAL LEFT

    MDR report key: 7767258 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07499
    Event Type
    Injury
    Date Received
    August 9, 2018
    Report Date
    October 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR DEVIATIONS A WITH THE FOLLOWING DEVIATIONS IDENTIFIED: PER PRODUCT DEVIATION REPORT, MINOR HANDLING SCRATCHES WERE PRESENT TO THE LATERAL CONDYLE ZONE 1. THE PART WAS REWORKED. NO MEDICAL RECORDS WERE PROVIDED. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 183402, VANGUARD TIBIAL BEARING, LOT # 474000; CATALOG #: 141210, BIOMET MAXIM PRIMARY TIBIAL TRAY, LOT # 806940; CATALOG #: 184782, SERIES A PATELLA PEG, LOT # 054040; CATALOG #: 141310, BIOMET I-BEAM STEM, LOT # 105650. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-07499, 07500, 07501, 07502, 07503. LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY TOTAL KNEE ARTHROPLASTY APPROXIMATELY 10 YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS NOTED TO HAVE PITTED EDEMA OCCURRING ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608288 VANGUARD FEMORAL LEFT PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 460210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other