BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT STD 31 3 PEG

    MDR report key: 9937812 · Received April 8, 2020

    Report

    Report Number
    0001825034-2020-01502
    Event Type
    Injury
    Date Received
    April 8, 2020
    Report Date
    May 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBV
    PMA / PMN Number
    K040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THE CONTACT WAS SENT THE INVESTIGATION RESULTS. 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 PRODUCT: VGXP XP INLK PRI TIB TRAY CATALOG # 195752, LOT # 716040; VGXP INTLK FEMORAL RT CATALOG # 195910, LOT # 872820; VGXP XP E1 TIB BRG RL CATALOG # 195773, LOT # 499430; VGXP XP E1 TIB BRG RM CATALOG # 195843, LOT # 433370; R & B BONE CEMENT CATALOG # UNKNOWN LOT # 82054447. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2020-01494, 0001825034-2020-01495, 0001825034-2020-01497, 0001825034-2020-01499.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS EXPERIENCED PAIN, SWELLING AND INSTABILITY SINCE HER PROCEDURE. PATIENT FALLS OFTEN ALLEGEDLY CAUSED BY THE KNEE IMPLANTS. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403636 SERIES A PAT STD 31 3 PEG PROSTHESIS, KNEE MBV ZIMMER BIOMET, INC. N/A 703050

    Patients

    Seq Age Sex Outcome Treatment
    1 Other