BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 36MM

    MDR report key: 8698922 · Received June 14, 2019

    Report

    Report Number
    3002806535-2019-00506
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    January 31, 2019
    Report Date
    September 6, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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 · 0

    (B)(4). 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 · 0

    IT WAS REPORTED BY THE HOSPITAL THAT AT A 2-YEAR FOLLOW-UP VISIT AFTER UNDERGOING PRIMARY RIGHT THA, THE PATIENT WAS EXPERIENCING INCREASED PAIN, DECREASED FLEXION, MOBILITY AND SATISFACTION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HOSPITAL THAT AT A 2-YEAR FOLLOW-UP VISIT AFTER UNDERGOING PRIMARY RIGHT THA, THE PATIENT WAS EXPERIENCING INCREASED PAIN, DECREASED FLEXION, MOBILITY AND SATISFACTION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: G7 PPS LTD ACET SHELL 50D, CATALOG #:010000662, LOT #: 3959139; MEDICAL PRODUCT: G7 NEUTRAL E1 LINER 36MM D CATALOG #:010000856 LOT #:3907483; MEDICAL PRODUCT: ECHO B-MTRC MP FP HO 8 CATALOG #:193108 LOT #: 688600. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT AT A 2-YEAR FOLLOW-UP VISIT AFTER UNDERGOING PRIMARY RIGHT THA, THE PATIENT WAS EXPERIENCING INCREASED PAIN, DECREASED FLEXION, MOBILITY AND SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493719 CER BIOLOXD OPTION HD 36MM HIP PROSTHESIS LZO BIOMET UK LTD. N/A 613600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other