BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL COMPONENT

    MDR report key: 7213358 · Received January 23, 2018

    Report

    Report Number
    0002648920-2018-00052
    Event Type
    Injury
    Date Received
    January 23, 2018
    Date of Event
    November 2, 2015
    Report Date
    January 23, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1822565-2015-02214. CONCOMITANT MEDICAL PRODUCTS - 00-1112-140-01 74854314 PALACOS R 1X40 SINGLE, 00-5964-050-10 62241580 NEXGEN LPS-FLEX FIXED NSM ART, 00-5970-000-10 56539305 PATIENT SPECIFIC BONE MODEL, 00-5970-000-14 56539304 LPS PATIENT SPECIFIC GUID, 00-5972-065-26 62249362 NEXGEN ALL-POLY PATELLA, 26 MM, 00-5980-057-03 62227580 NEXGEN PRECOAT STEMMED TIBIAL, 00-5996-018-51 62184106 NEXGEN LPS OPTION FEMORAL, 00-6250-065-30 62211409 BONE SCREW 6.5X30 SELF-TAP, 00-6250-065-30 62249792 BONE SCREW 6.5X30 SELF-TAP, 98-0002-001-13 CEM ST/PRCT TIB/FLEX (NSM)SURF/ STD, 98-8500-000-01 PATIENT SPECIFIC SURG BONE MODEL. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Description of Event or Problem · 1

    PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 2 YEARS POST-IMPLANTATION ALLEGEDLY DUE TO AND LOOSENING OF UNSPECIFIED COMPONENT. PATIENT FURTHER ALLEGED THAT FLUID NEEDED DRAINED FROM THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55118 TIBIAL COMPONENT KNEE, PROSTHESIS JWH ZIMMER MANUFACTURING B.V. 62227580

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R