BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE -6

    MDR report key: 7768835 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07891
    Event Type
    Injury
    Date Received
    August 9, 2018
    Report Date
    October 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE IS NOT REPORTABLE AS IT WAS NOT INVOLVED IN THE EVENT AND DID NOT MALFUNCTION. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    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. 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 - 07887, 0001825034 - 2018 - 07888, 0001825034 - 2018 - 07889, 0001825034 - 2018 - 07890.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST IMPLANTATION, THE PATIENT SUSTAINED A FALL, WAS ADMITTED TO THE HOSPITAL, AND FOUND TO BE SEPTIC. NO NOTATION OF ANY CULTURE RESULTS. PICC LINE WAS PLACED FOR ADMINISTRATION OF IV ANTIBIOTICS. THE PATIENT SUBSEQUENTLY DEVELOPED A DVT BEHIND THE PICC LINE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611173 CER OPTION TYPE 1 TPR SLEVE -6 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 411520

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R