BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 7351191 · Received March 19, 2018

    Report

    Report Number
    0001825034-2018-01913
    Event Type
    Injury
    Date Received
    March 19, 2018
    Report Date
    May 24, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS EVENT HAS PREVIOUSLY BEEN REPORTED. THIS REPORT SHOULD BE VOIDED. THIS EVENT WAS PREVIOUSLY REPORTED UNDER THE FOLLOWING REPORTS: 0001825034-2018-02103, 0001825034-2018-02103-1.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: UNKNOWN, UNKNOWN LINER, UNKNOWN; UNKNOWN, UNKNOWN CUP, UNKNOWN; UNKNOWN, UNKNOWN HEAD, UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01911; 0001825034 - 2018 - 01912; 0001825034 - 2018 - 01910.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION ON AN UNKNOWN DAY FOR AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194333 UNKNOWN STEM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O