BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP E1 TIB BRG RL 9X71

    MDR report key: 7291837 · Received February 23, 2018

    Report

    Report Number
    0001825034-2018-01338
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    August 13, 2014
    Report Date
    February 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK122160
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT- (B)(4). CONCOMITANT PRODUCTS: PART 195203, LOT 088040- VGXP INTLK FMRL RT 60; PART 195249, LOT 881530- VNGD XP INLK PRI TIB TRAY 71MM; PART 195402, LOT 946150- 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 0001825034-2018-01336, MFR 0001825034-2018-01337, MFR 0001825034-2018-01339. 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 504 - 3 & 6 MONTH POST-OPERATIVE MODERATE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135177 VGXP XP E1 TIB BRG RL 9X71 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 052270

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other