BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP E1 TIB BRG LM 10X79

    MDR report key: 8349344 · Received February 19, 2019

    Report

    Report Number
    0001825034-2019-00409
    Event Type
    Injury
    Date Received
    February 19, 2019
    Date of Event
    January 7, 2019
    Report Date
    August 8, 2019
    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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. 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). CONCOMITANT MEDICAL PRODUCTS: VGXP XP E1 TIB BRG LM 10X79; P/N: 195892, L/N: 257460; VGXP XP E1 TIB BRG LL 10X79; P/N: 195822, L/N: 168570; VGXP INTLK FEMORAL LT 75; P/N: 195926, L/N: 162120; VGXP XP INLK PRI TIB TRAY 79MM; P/N: 195758, L/N: 999400; SERIES A PAT STD 34 3 PEG; P/N: 184766, L/N: 346140. REPORT SOURCE FOREIGN: (B)(6). 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 - 2019 - 00410; 0001825034 - 2019 - 00412. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY APPROXIMATELY ONE YEAR AGO. SUBSEQUENTLY, THE PATIENT WAS READMITTED TO THE HOSPITAL AND UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO INADEQUATE RANGE OF MOVEMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143672 VGXP XP E1 TIB BRG LM 10X79 PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 257460

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other