BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEM EXTENSION

    MDR report key: 6998766 · Received November 3, 2017

    Report

    Report Number
    0002648920-2017-00669
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    June 26, 2017
    Report Date
    January 2, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT WILL NOT BE RELEASED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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

    CONCOMITANT MEDICAL PRODUCTS: 00-5880-013-02 NG ROT.HINGE KNEE FEM SZ C RIGHT 63490633 , 00-5990-033-20 10MM DISTAL AUGMENT (FEMORAL C) 63378697, 00-5990-033-10 5MM DISTAL AUGMENT (FEMORAL C) 63358458. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES 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.

    Additional Manufacturer Narrative · 1

    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 THE FINAL STEM WAS TALLER THAN THE STEM PROVISIONAL. ONCE IMPLANTED, THE SIZING VARIANCE WAS NOTED ALONG WITH A FRACTURE OF THE EPIPHYSIS. THE CEMENT HAD ALREADY HARDENED AND REMOVAL DELAYED THE SURGERY OVER AN HOUR. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780572 NEXGEN STEM EXTENSION PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 63272536

    Patients

    Seq Age Sex Outcome Treatment
    1 Other