BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTICAL BONE SCR 42MM

    MDR report key: 2232230 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15654
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HSB
    PMA / PMN Number
    K871539
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR ALL OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. PROVIDED INFO STATES THE SURGEON REMOVED A CAPTURED HIP SCREW AND CONVERTED TO A THA. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAIN. QTY 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTICAL BONE SCR 42MM 87HSB; 87HWC HSB DEPUY ACE S.A. 'R.L. NA DGBBP1

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention