BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS OPTION FEMORAL COMPONENT

    MDR report key: 5550331 · Received April 6, 2016

    Report

    Report Number
    1822565-2016-00900
    Event Type
    Injury
    Date Received
    April 6, 2016
    Report Date
    June 3, 2017
    Manufacturer
    ZIMMER INC
    Product Code
    NJL
    PMA / PMN Number
    PSEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICE USED: CATALOG #00598004702, NEXGEN STEMMED PRECOAT TIBIAL COMPONENT, LOT #62900444 - MANUFACTURED BY ZIMMER (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). CONCOMITANT MEDICAL PRODUCT: NEXGEN PMMA PRE-COATED STEMMED TIBIAL COMPONENT, CATALOG #00598004702, LOT #62900444; LPS-FLEX FIXED ARTICULAR SURFACE EF/5-6 10MM, CATALOG #00596404010, LOT #62525701; NEXGEN ALL POLY PATELLA 35MM DIA, CATALOG #00597206535, LOT #62735536. PMA: P060037/S04. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DEVIATIONS OR ANOMALIES RELEVANT TO THE REPORTED EVENT. REVIEW OF COMPATIBILITY OF THE IMPLANTED DEVICES IDENTIFIED NO ISSUES. A COMPLAINT HISTORY SEARCH WAS CONDUCTED FOR EACH DEVICE IN THE EVENT. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THESE ITEMS' REPORTED PART AND LOT COMBINATIONS. THE SEARCH ALSO IDENTIFIED NO OTHER COMPLAINTS WITH SAME OR SIMILAR ISSUE BY LOT NUMBER. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. BONE CEMENT USED IN THE IMPLANTATION IS UNKNOWN. THE NEXGEN PACKAGE INSERT ADVISES THAT METAL SENSITIVITY IS A POSSIBLE ADVERSE EFFECT FOR THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. 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 IS REPORTED THAT THE PATIENT IS EXPERIENCING A NICKEL ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207638 NEXGEN LPS OPTION FEMORAL COMPONENT NJL NJL ZIMMER INC 62436450

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other