BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGAURD CR FEMORAL COMPONENT

    MDR report key: 7917934 · Received September 28, 2018

    Report

    Report Number
    0001825034-2018-09208
    Event Type
    Injury
    Date Received
    September 28, 2018
    Date of Event
    December 3, 2010
    Report Date
    July 23, 2019
    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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 WERE FOUND. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS: VANGAURD CR TIBIAL BEARING CAT#: 183564, LOT#: 092330 ; BMET REGENX PRI TIB TRAY CAT#: 141275, LOT#: 640070 ; REGENEREX TAPER CAP CAT#: 141269, LOT#: 868070 ; RGX 3 PEG SER A PATELLA 37MM CAT#: 141358, LOT#: 826590 . CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED 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 - 09208, 0001825034 - 2018 - 09207.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED FROM ADHESIVE CAPSULITIS IN THE RIGHT KNEE AND UNDERWENT MANIPULATION UNDER ANESTHESIA THREE MONTHS AFTER RIGHT KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759613 VANGAURD CR FEMORAL COMPONENT PROSTHESIS, HIP JWH ZIMMER BIOMET, INC. N/A 146000

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R