BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 VIT E HIGH WALL LNR 40MM I

    MDR report key: 11330405 · Received February 15, 2021

    Report

    Report Number
    0001825034-2021-00480
    Event Type
    Injury
    Date Received
    February 15, 2021
    Date of Event
    January 15, 2021
    Report Date
    March 8, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 1822565 ZIMMER.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 1822565 ZIMMER

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT# 650-1067 CER OPTION TYPE 1 TPR SLEEVE +3 LOT# 3031101, CAT# 110010271 G7 OSSEOTI MULTIHOLE 66MM I LOT#R3713970A, CAT# 650-1058 CER BIOLOXD OPTION HD 40MM LOT# 2993794, CAT#11-300817 ARCOS 17X150MM SPL TPR DIST LOT#838140. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-00476, 0001825034-2021-00479, 0001825034-2021-00499.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 11 MONTHS POST IMPLANTATION DUE TO AN INFECTION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223409 G7 VIT E HIGH WALL LNR 40MM I PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64714864

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R SEE H10 NARRATIVE