BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP E1 TIB BRG LL 12X79

    MDR report key: 13873586 · Received March 24, 2022

    Report

    Report Number
    0001825034-2022-00645
    Event Type
    Injury
    Date Received
    March 24, 2022
    Date of Event
    February 10, 2021
    Report Date
    July 8, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2022-00644, 0001825034-2022-00666. CONCOMITANT MEDICAL PRODUCTS-MEDICAL PRODUCT VGXP INTLK FEMORAL LT 67.5 ITEM# 195923 LOT# 778660 VGXP AS E1 TIB BRG LM/RL 14X79 ITEM# 195568 LOT# 869170 SERIES A PAT THN 34 3 PEG ITEM# 184786 LOT# 213840 VNGD XP CR INTLK TIB TRAY 79MM ITEM# 195276 LOT# 320590 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.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED IN ERROR. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. THIS PRODUCT WAS IMPLANTED ON THE RIGHT SIDE AND IS NOT RELATED TO THIS REVISION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO YEARS SEVEN AND A HALF MONTHS POST IMPLANTATION DUE TO DUE TO INSTABILITY, TISSUE DAMAGE, AND PERIPROSTHETIC FRACTURE CAUSED BY A FALL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED IN ERROR. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. THIS PRODUCT WAS IMPLANTED ON THE RIGHT SIDE AND IS NOT RELATED TO THIS REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864227 VGXP XP E1 TIB BRG LL 12X79 PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 874780

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R