BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REGENEREX SHELL

    MDR report key: 7763283 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-06960
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    January 22, 2013
    Report Date
    October 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TAPERLOC MICRO LAT FMRL 17.5MM, PN 15-103209, LN UNKNOWN; SELEX/MAGNUM MOD HD 40MM +9, PN S991140, LN UNKNOWN; UNKNOWN MAX-ROM, PN UNKNOWN, LN UNKNOWN; UNKNOWN MAGNUM TAPER, PN UNKNOWN, LN UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2018-06959. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS NOTED TO HAVE ACETABULAR FINDINGS OF THE RIGHT HIP DEMONSTRATE RADIOLUCENCY ZONE II, ZONE III, AND STEM SUBSIDENCE APPROXIMATELY FOUR YEARS POST IMPLANTATION. 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
    603540 UNKNOWN REGENEREX SHELL PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other