BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS R + G (1X40)

    MDR report key: 12017263 · Received June 17, 2021

    Report

    Report Number
    0001822565-2021-01668
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    May 21, 2021
    Report Date
    September 7, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: B5, H10 . THIS SUPPLEMENTAL REPORT IS TO VOID THE INITIAL AS ZIMMER BIOMET DOES NOT HAVE RESPONSIBILITY FOR THIS PRODUCT.

    Description of Event or Problem · 0

    CORRECTION, ZIMMER BIOMET DOES NOT HAVE RESPONSIBILITY FOR THIS PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT : NEXGEN STEM 00598801115 LOT 61214730, ROTATING HINGE KNEE FEMORAL 00588001502 LOT 61314950 KRO PROSTHESIS, KNEE , NEXGEN FEMORAL AUGMENT 00599003521 LOT 60880980, NEXGEN FEMORAL AUGMENT 00599003524 LOT 61737801, ARTICULAR SURFACE 00588005023 LOT 61718734, UNKNOWN TIBIAL COMPONENT . THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 001822565-2021-01664, 0001822565-2021-01665, 0001822565-2021-01666, 0001822565-2021-01667.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION KNEE ARTHROPLASTY TEN YEARS POST IMPLANTATION DUE TO LOOSENING OF THE FEMORAL COMPONENTS AFTER A FALL. THE CAUSE OF THE FALL IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910886 PALACOS R + G (1X40) BONE CEMENT LOD ZIMMER BIOMET, INC. N/A 72474274

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R