BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS 135° 4HO L78 SST

    MDR report key: 2870681 · Received December 12, 2012

    Report

    Report Number
    2520274-2012-03880
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    April 11, 2010
    Manufacturer
    SYNTHES
    Product Code
    HRS
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE KTT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE (B)(6) COMPLAINT HANDLING UNIT REPORTED THAT A SCREW WAS BLOCKED IN THE PLATE. AFTER THE INITIAL SURGERY, A LAG SCREW WAS CUTTING OUT OF FEMORAL HEAD AND A SURGERY WAS PLANNED TO REPLACE THIS LAG SCREW WITH A SHORTER LENGTH SCREW. DURING THIS PROCEDURE THE SURGEON WAS UNABLE TO SEPARATE THE PLATE FROM THE LAG SCREW. ALL IMPLANTS WERE THEN REMOVED WITH DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DHS 135° 4HO L78 SST DYNAMIC HIP SYSTEM HRS SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention