BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER NEXGEN ARTICUL

    MDR report key: 6535664 · Received May 1, 2017

    Report

    Report Number
    0001822565-2017-02886
    Event Type
    Injury
    Date Received
    May 1, 2017
    Date of Event
    June 9, 2016
    Report Date
    September 20, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK960279
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS DISCARDED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS: PALACOS BONE CEMENT CATALOG # 00-1112-140-01 LOT # 69404225, PALACOS BONE CEMENT CATALOG # 00-1112-140-01 LOT # 69404225, ZIMMER NEXGEN ALL POLY PATELLA SIZE 35MM CATALOG # 00-5972-065-35 LOT # 61483613, ZIMMER NEXGEN PRECOAT STEMMED TIBIA SIZE 6 CATALOG # 00-5980-047-02 LOT # 61422050, ZIMMER NEXGEN OFFSET STEM EXTENSION 12MM CATALOG # 00-5988-020-12 LOT # 61242661, ZIMMER NEXGEN OFFSET STEM EXTENSION 15MM CATALOG # 00-5988-020-15 LOT # 61350683, ZIMMER NEXGEN LCCK OPTION FEMORAL SIZE G LEFT CATALOG # 00-5994-017-91 LOT # 61389780.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE PATIENT'S INFECTION OCCURED GREATER THAN A YEAR POST OP AND THE PATIENT HAD PRE-EXISTING CONDITIONS CAUSING THE INFECTION. THE INITIAL REPORT WAS MADE IN ERROR AND SHOULD BE VOIDED. 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 WAS REPORTED THAT A PATIENT HAD A REVISION PROCEDURE OF THE POLYETHYLENE INSERT DUE TO PAIN AND INFECTION. NO ADDITIONAL PATIENT CONCRESCENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315892 ZIMMER NEXGEN ARTICUL NEXGEN TOTAL KNEE LCCK ARTICULAR SURFACE SIZE G 5/6, 12MM JWH ZIMMER, INC. 61268386

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention