BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE -6

    MDR report key: 7764123 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-07030
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    June 8, 2014
    Report Date
    October 8, 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 · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. REVIEW OF OPERATIVE NOTES STATES THAT PATIENT UNDERWENT A TWO-STAGE REVISION DUE TO INFECTION. DURING THE SECOND STAGE, LARGE AMOUNTS OF HETEROTOPIC OSSIFICATION TISSUE WAS NOTED AND EXCISED. PATIENT EXPERIENCE ABOUT 1200CC OF BLOOD LOSS REQUIRING 4 UNITS OF PACKED RED BLOOD CELLS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: ITEM # 51-107200, STEM, LOT # 3140308. ITEM # 650-1057, HEAD, LOT # 893830. ITEM # 010000668, SHELL, LOT # 3147335. ITEM # 010000860, LINER, LOT # 3266167. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 07026, 0001825034 - 2018 - 07027, 0001825034 - 2018 - 07028, 0001825034 - 2018 - 07029.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT THE FIRST STAGE OF A TWO-STAGE REVISION DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604554 CER OPTION TYPE 1 TPR SLEVE -6 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 411520

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R