BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN FEMORAL AUGMENTS

    MDR report key: 7240013 · Received February 4, 2018

    Report

    Report Number
    0001822565-2018-00508
    Event Type
    Injury
    Date Received
    February 4, 2018
    Date of Event
    January 9, 2018
    Report Date
    June 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK946150
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: NEXGEN ROTATING HINGE KNEE FEMORAL COMPONENT CAT#: 00588001501, LOT#: 61511043, NEXGEN FEMORAL AUGMENTS CAT#: 00599003510, LOT#: 61338227, NEXGEN STEM EXTENSION CAT#: 00598801112, LOT#: 60592147, NEXGEN FEMORAL AUGMENTS CAT#: 00-5990-035-10, LOT#: 60308860. FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001822565 - 2018 - 00506, 0001822565-2018-00507, 0001822565 - 2018 - 00508, 0001822565-2018-00509. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED EIGHT YEARS AFTER KNEE ARTHROPLASTY DUE TO FEMORAL CONE FRACTURE AND DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83482 NEXGEN FEMORAL AUGMENTS PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 61643130

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R