BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 40MM

    MDR report key: 6980337 · Received October 26, 2017

    Report

    Report Number
    0001825034-2017-09640
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    September 27, 2017
    Report Date
    January 9, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOLOX FEMORAL HEAD, UNKNOWN PART/LOT, 110010245 G7 OSSEOTI 4 HOLE SHELL 54 MM F 6022434, 010000997 G7 SCREW 6.5 MM X 20 MM 60628020, 010000999 G7 SCREW 6.5 MM X 30 MM 6073815, 010000936 G7 HI-WALL E1 LINER 36 MM F 6078657, 010000936 G7 HI-WALL E1 LINER 36 MM F 6078657, 192414 ECHO POR FMRL RED NC 14 X 150 MM 624300. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO CORRECT IMPLANT SIZING SAME DAY AS INITIAL PROCEDURE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759814 CER BIOLOXD OPTION HD 40MM PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 2904567

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R