BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DB10 STEM

    MDR report key: 7600893 · Received June 14, 2018

    Report

    Report Number
    3006946279-2018-00200
    Event Type
    Injury
    Date Received
    June 14, 2018
    Report Date
    June 14, 2018
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LPH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). PRODUCT NOT RETURNED AND BATCH NOT COMMUNICATED. AS BIOMET FRANCE DID NOT RECEIVE ANY INFORMATION ABOUT THE INVOLVED BATCH NUMBER AND AS THE PRODUCT HAS NOT BEEN RETURNED, BIOMET FRANCE WAS NOT ABLE TO PERFORM ANY BATCH AND MANUFACTURING DOCUMENTATION REVIEW AND PRODUCT ANALYSIS COULD NOT BE PERFORMED. ACCORDING TO THE AVAILABLE DATA, THE EXACT ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, THERE IS NO EVIDENCE THAT THE ROOT CAUSE IS RELATED TO THE PRODUCT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED VARIOUS COMPLICATIONS IN THE JOURNAL ARTICLE "MORE COMPLICATIONS IN UNCEMENTED COMPARED TO CEMENTED HEMIARTHROPLASTY FOR DISPLACED FEMORAL NECK FRACTURE: A RANDOMIZED CONTROLLED TRIAL OF 201 PATIENTS, WITH ONE YEAR FOLLOW UP" VARIOUS COMPLICATIONS REPORTED RELATED TO A DB10 STEM: TWO POSTOPERATIVELY PERIPROSTETIC FRACTURES WITHIN ONE YEAR AFTER UNCEMENTED HEMIARTHROPLASTY USING DB10 STEM. TWELVE INTRAOPERATIVELY PERIPROSTETIC FRACTURES WITHIN ONE YEAR AFTER UNCEMENTED HEMIARTHROPLASTY USING DB10 STEM. FIVE DISLOCATIONS WITHIN ONE YEAR AFTER UNCEMENTED HEMIARTHROPLASTY USING DB10 STEM. THIS MEDWATCH REPORT IS FOR ONE OF THE DISLOCATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444666 DB10 STEM DB10 STEM LPH BIOMET FRANCE S.A.R.L.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention