BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 7147270 · Received December 27, 2017

    Report

    Report Number
    3007963827-2017-00294
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    November 3, 2017
    Report Date
    January 12, 2018
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK060370
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT AND ITS PACKAGING WERE RETURNED AND FROM THE RETURNED PRODUCT EVALUATION IT WAS DETERMINED THAT, CARTON EXHIBITS DAMAGE / PUNCTURED AND THE CAVITIES ARE CRACKED / STRESSED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE FOR THE REPORTED ISSUE IS ATTRIBUTED TO BE TRANSIT DAMAGE /PRODUCT DAMAGED DURING SHIPMENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE G LEFT, CATALOG # 00576401751, LOT # 62385297. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 3007963827 - 2017 - 00293.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INNER CONTAINER OF THE BOX WAS BROKEN. THE BOX WAS NOTICED TO BE BENT AND CREASED AND NOTICED THAT THE CONTAINERS INSIDE WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926736 NEXGEN LPS-FLEX FEMORAL COMPONENT PROSTHESIS KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 62762793

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR