BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE -3

    MDR report key: 7960158 · Received October 12, 2018

    Report

    Report Number
    0001825034-2018-09674
    Event Type
    Injury
    Date Received
    October 12, 2018
    Date of Event
    March 7, 2018
    Report Date
    October 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: ITEM # 650-1058, HEAD, LOT # UNK; ITEM # 11-301321, STEM, LOT # 156040; ITEM # 11-300919, DISTAL TAPER, LOT # 945120; ITEM # UNK, HIP-UNKNOWN-CUPS-UNK, LOT # UNK; ITEM # UNK, HIP-UNKNOWN-LINERS-UNK, LOT # UNK. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2018 -05647, 0001825034 -2018 -05643, 0001825034 -2018 -05645, 0001825034 -2018 -05646, 0001825034 - 2018 - 05639.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT ASPIRATION OF THE LEFT HIP APPROXIMATELY 6 YEARS POST LEFT HIP REVISION SURGERY FOR UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802026 CER OPTION TYPE 1 TPR SLEVE -3 HIP PROSTHESIS LZO ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other