BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE -3 PE 1

    MDR report key: 7289623 · Received February 22, 2018

    Report

    Report Number
    0001825034-2018-01266
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    September 17, 2016
    Report Date
    February 21, 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
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS 110010269 G7 OSSEOTI MULTIHOLE 62 MM H 3594155, UNKNOWN STEM, 010000870 G7 NEUTRAL E1 LINER 44 MM H 3273288, 650-1059 CER BIOLOXD OPTION HD 44 MM 035380, 650-1065 CER OPTION TYPE 1 TPR SLEVE -3 PE 1 183380. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED SERIOUS DRAINAGE SEVERAL DAYS POST-REVISION AND UTILIZED A CRUTCH FOR AMBULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134102 CER OPTION TYPE 1 TPR SLEVE -3 PE 1 HIP PROSTHESIS LZO ZIMMER BIOMET, INC. N/A 183380 

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R