BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP E1 TIB BRG RL 10X71

    MDR report key: 7279778 · Received February 19, 2018

    Report

    Report Number
    0001825034-2017-10881
    Event Type
    Injury
    Date Received
    February 19, 2018
    Date of Event
    April 3, 2014
    Report Date
    February 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK122160
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT- (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART 195203, LOT 503670- VGXP INTLK FMRL RT 60, PART 195251, LOT 936260- VNGD XP INLK PRI TIB TRAY 75MM, PART 195333, LOT 867980 - VGXP XP E1 TIB BRG RL 10X71, PART 195402, LOT 868540- VGXP XP E1 TIB BRG RM 9X71. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: MFR 0001825034-2018-10875, MFR 0001825034-2018-10876, MFR 0001825034-2018-10881, MFR 0001825034-2018-10882. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THIS COMPLAINT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    PAIN AND DISCOMFORT 6 MONTHS AND 1 YEAR POST A TOTAL KNEE ARTHROPLASTY PROCEDURE ON THE RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123184 VGXP XP E1 TIB BRG RL 10X71 PROSTHESIS,KNEE MBH ZIMMER BIOMET, INC. N/A 867980

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other