BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 6394747 · Received March 10, 2017

    Report

    Report Number
    0001822565-2017-01624
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    February 7, 2017
    Report Date
    September 27, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: NEXGEN LPS-FLEX ARTICULAR SURFACE, CATALOG #: 00596405010, LOT #: 60296076. NEXGEN STEMMED TIBIAL COMPONENT, CATALOG #: 00598605701, LOT #: 60275623. THIS PRODUCT IS MANUFACTURED BY ZIMMER (B)(4) AND DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER P060037. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE HOSPITAL HAS RETAINED THE DEVICE. 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: 0001822565-2017-01628 AND 0001822565-2017-00186.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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 · 1

    IT HAS BEEN REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY TWELVE YEARS AGO. CONSEQUENTLY, THE PATIENT'S FEMORAL, TIBIAL AND ARTICULAR SURFACE COMPONENTS HAVE BEEN REVISED DUE TO LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176801 NEXGEN LPS-FLEX FEMORAL COMPONENT PROSTHESIS, KNEE NJL ZIMMER, INC. 60296076

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R