BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D RIGHT

    MDR report key: 6231423 · Received January 6, 2017

    Report

    Report Number
    0001822565-2017-00094
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    October 28, 2016
    Report Date
    February 23, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK991581
    Removal / Correction Number
    ZFA 2010-013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR FURTHER EVALUATION. UNABLE TO REVIEW DEVICE HISTORY RECORDS AS LOT IDENTIFICATION IS UNKNOWN. THESE PRODUCTS ARE USED FOR TREATMENT. THE DEVICES WERE REVIEWED FOR COMPATIBILITY. IT WAS FOUND THAT THE ARTICULAR SURFACE AND THE FEMUR WERE NOT COMPATIBLE WITH EACH OTHER. AN INTERNAL INVESTIGATION WAS INITIATED FOR AN INCREASED RATE OF REVISION IN THE MIS TIBIA DUE TO LOOSENING. THE RESULT OF THE INVESTIGATION WAS THE IMPLEMENTATION OF FIELD ACTION WHICH HIGHLY ENCOURAGED SURGEONS TO UTILIZE THE DROP DOWN STEM EXTENSION AND TO CONFIRM THE PROPER CEMENTING TREATMENT WAS USED FOR THE MIS TIBIAL COMPONENT. PER THE MIS TIBIA SURGICAL TECHNIQUE ¿USE OF A DROP DOWN STEM IS STRONGLY RECOMMENDED TO PROVIDE ADJUNCTIVE STABILITY TO THE CEMENTED CONSTRUCT¿.FAILING TO USE A DROP DOWN STEM EXTENSION¿..MAY LEAD TO EARLY LOOSENING OF THE PROSTHESIS.¿ ADDITIONALLY PER THE PACKAGING INSERT FOR THE ARTICULAR SURFACE ¿DO NOT USE LPS OR LPS-FLEX FEMORAL COMPONENTS WITH LPS-FLEX PROLONG ARTICULAR SURFACES UNLESS THE PART NUMBER OF THE FEMORAL COMPONENT HAS A 51 OR 52 PART NUMBER SUFFIX. USE OF OTHER SUFFIX LPS OR LPS-FLEX FEMORAL COMPONENTS MAY INCREASE THE RISK OF ARTICULAR SURFACE SPIN FRACTURE.¿ THEREFORE, ROOT CAUSE FOR THE ASSOCIATED EVENT IS AN INAPPROPRIATE USE OF THE DEVICES. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001822565-2017-00093-1/00094-1/00095-1).

    Additional Manufacturer Narrative · 1

    ITEM NAME: NEXGEN PROLONG LPS FLEX ARTICULAR SURFACE SIZE CD 10MM HEIGHT, ITEM NUMBER: 00596203010, LOT NUMBER: 61569292; THERAPY DATE (B)(6) 2016. ITEM NAME: UNKNOWN NEXGEN TIBIAL, ITEM NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN; THERAPY DATE (B)(6) 2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED FOR FEMORAL AND TIBAL LOOSENING. THE SURGEON NOTICED STAINING AND WEAR ON THE ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14515 NEXGEN FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D RIGHT PROTHESIS, KNEE JWH ZIMMER, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR