BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT STD 28 3 PEG

    MDR report key: 9752263 · Received February 25, 2020

    Report

    Report Number
    0001825034-2020-00881
    Event Type
    Injury
    Date Received
    February 25, 2020
    Date of Event
    February 28, 2017
    Report Date
    February 25, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304431638
    PMA / PMN Number
    K040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD TIBIAL BEARING 10X63/67MM CATALOG 183620 LOT 826490, BIOMET CRUCIATE TRAY 63MM CATALOG 141231 LOT J3734099, VANGUARD FEMORAL PEGS SET 2 CATALOG 183099 LOT 0827330, VANGUARD FEMORAL LEFT CATALOG 183128 LOT J3721221, PALACOS R 1X40 BONE CEMENT CATALOG 00111214001 LOT 83264474. OFFICE NOTES PROVIDED CONFIRM THE PATIENT WAS EXPERIENCING PAIN AND UNDERWENT MANIPULATION UNDER ANESTHESIA. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND STIFFNESS AND SUBSEQUENTLY UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY SIX MONTHS POST LEFT KNEE ARTHROPLASTY DUE TO ARTHROFIBROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212264 SERIES A PAT STD 28 3 PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 818530 00880304431638

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R