BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPCS COCR PRIM HO 12/14 SZ 2

    MDR report key: 7489374 · Received May 5, 2018

    Report

    Report Number
    1020279-2018-00861
    Event Type
    Injury
    Date Received
    May 5, 2018
    Date of Event
    April 6, 2018
    Report Date
    July 10, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDI
    UDI-DI
    03596010462152
    PMA / PMN Number
    K823727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. THE CLINICAL/MEDICAL TEAM CONCLUDED, NO CLINICAL SUPPORTING DOCUMENTS WERE PROVIDED TO CONDUCT A THOROUGH ANALYSIS OF THE REPORTED ISSUE. NO MEDICAL ASSESSMENT CAN BE RENDERED. A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THE CORRESPONDING PRODUCTS DID NOT REVEAL ANY DEVIATION FROM THE STANDARD MANUFACTURING PROCESSES. A REVIEW OF COMPLAINT HISTORY FOR THE LISTED PARTS REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCHES. PRODUCT WAS STERILIZED ACCORDING TO STERILIZATION RELEASE DOCUMENTATION FROM QUALITY CONTROL. WITHOUT THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED.

    Description of Event or Problem · 1

    PRODUCT EXPERIENCE. ORIGINAL SURGERY: DR (B)(6) APPROX 2 WEEKS AGO (B)(6). REVISION CAUSE: INFECTION. CASE: CPCS SIZE 2 HO CEMENTED STEM REMOVED. CPCS SIZE 1 HO STEM IMPLANTED IN REMAINING CEMENT MANTLE. SIZE 36 +8 COBALT CHROME HEAD REMOVED. NEW HEAD IMPLANTED (SAME SIZE AND MATERIAL). NO REPORT REQUIRED FOR SURGEON. SURGEON HAS NOT IMPLICATED IMPLANT AS A CAUSE OF REVISION . NO HOSPITAL REPORT REQUIRED . IMPLANT WILL NOT BE RETURNED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331891 CPCS COCR PRIM HO 12/14 SZ 2 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI SMITH & NEPHEW, INC. 17DM12155 03596010462152

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R