BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER EXTRA EXT. OFFSET

    MDR report key: 8025728 · Received October 31, 2018

    Report

    Report Number
    0002648920-2018-00783
    Event Type
    Injury
    Date Received
    October 31, 2018
    Date of Event
    July 30, 2013
    Report Date
    February 28, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    K960658
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 0002648920-2017-00580. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED 25 DAYS POST IMPLANTATION DUE TO PERIPROSTHETIC FRACTURE. STEM, HEAD AND LINER WERE REVISED. NO ADDITIONAL INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00801802803, FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER, 62315635; 00801102032, ALLEN PLUG , 61068465; RM 4901 000 5, COMPETITOR CUP, 1210247A; RM 5110 003 5, COMPETITOR LINER, 1207253A. REPORT SOURCE: EVENT REPORTED BY (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE LOCATION OF THE PRODUCT IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL PRIMARY LEFT HIP REPLACEMENT. SUBSEQUENTLY THE PATIENT EXPIRED APPROXIMATELY 25 DAYS POST OPERATIVE DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864079 FEMORAL STEM 12/14 NECK TAPER EXTRA EXT. OFFSET PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 61292753

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| H| R