BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH

    MDR report key: 8414831 · Received March 12, 2019

    Report

    Report Number
    0002648920-2019-00181
    Event Type
    Injury
    Date Received
    March 12, 2019
    Date of Event
    August 27, 2018
    Report Date
    April 18, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 0002648920-2018-00707 THEREFORE, THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 0002648920-2018-00707.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00801803202, FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER, 63775882; 0100013509, DURASUL®, ALPHA INSERT, HOODED, II/32, 2920752; 4265, ALLOFIT S SHELL SIZE 52, 2920056. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2019-00180. 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 THE PATIENT'S RIGHT HIP WAS REVISED APPROX 5 MONTHS POST IMPLANTATION DUE TO INFECTION. TEMPORARY CEMENTED STEM WERE IMPLANTED TO TREAT INFECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206699 FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 63895896

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R