BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP E1 TIB BRG RM 11X63

    MDR report key: 7288098 · Received February 21, 2018

    Report

    Report Number
    0001825034-2018-01249
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    October 4, 2016
    Report Date
    February 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT- (B)(4). CONCOMITANT PRODUCTS: PART 195908, LOT 729510- VGXP INTLK FEMORAL RT 60; PART 195752, LOT 963440- VGXP XP INLK PRI TIB TRAY 65MM; PART 195774, LOT 797780- VGXP XP E1 TIB BRG RL 11X63; PART 195844, LOT 797890- VGXP XP E1 TIB BRG RM 11X63. 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 0001825034-2018-01245, MFR 0001825034-2018-01246, MFR 0001825034-2018-01248, MFR 0001825034-2018-01249. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORT EVENT WAS NOT REPORTED. 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

    CLINICAL STUDY 505 - REPORTED PAIN POST-OP RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131053 VGXP XP E1 TIB BRG RM 11X63 PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 797890

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other