BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA POLY LINER, I.D. 36MM, #L

    MDR report key: 3122474 · Received May 9, 2013

    Report

    Report Number
    3008021110-2013-00005
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BY THE EVENT INFO, WE KNOW THAT THE INFECTION WAS CAUSED BY (B)(6), AND IT OCCURRED SOON AFTER ORIGINAL SURGERY, AS THE IMPLANT DURATION "IN VIVO" IS 45 DAYS ONLY. WE KNOW THAT, DURING REVISION SURGERY, THE SURGEON EXPLANTED THE FEMORAL HEAD AND THE POLY LINER, LEAVING IMPLANTED THE FEMORAL STEM AND THE ACETABULAR CUP. WE CHECKED THE STERILIZATION CHARTS OF THE LOT # OF ALL THE COMPONENTS (THE EXPLANTED LINER AND FEMORAL HEAD, PLUS THE NON-EXPLANTED STEM AND CUP), WITHOUT FINDING ANY ANOMALY. ALL THE COMPONENTS WERE REGULARLY STERILIZED BEFORE PUTTING THEM ON THE MARKET. NO FURTHER INFO (E.G. X-RAYS, EXPLANTS) IS AVAILABLE, THEREFORE, A DEEPER ANALYSIS IS NOT POSSIBLE. WE KNOW THAT (B)(6) INFECTION IS CAUSED BY (B)(6). THE (B)(6) IS A BACTERIUM PRESENT ON THE SKIN OF ABOUT HALF THE ADULT POPULATION, AND THIS INFECTION MAY OCCUR AFTER INVASIVE PROCEDURES PERFORMED IN HOSP, AS A RESULT OF THE (B)(6) ENTERING THE HUMAN BODY. WE BELIEVE THAT THE DEVICES THEMSELVES ARE NOT THE CAUSE OF THE INFECTION. IT'S LIKELY THAT THE BACTERIAS, PRESENT IN THE ENVIRONMENT OR ON PT SKIN, ENTERED HER BODY DURING THE ORIGINAL SURGERY, LEADING TO THE INFECTION. NO CORRECTIVE ACTIONS FOR THIS SPECIFIC CASE. AN INFECTION IS A RARE ALTHOUGH POSSIBLE EVENT, AND WE BELIEVE THAT THE DEVICES THEMSELVES (ALL REGULARLY STERILIZED BEFORE THE ORIGINAL SURGERY) ARE NOT THE CAUSE OF THIS INFECTION. ALSO, WE DID NOT RECEIVE ANY SIMILAR COMPLAINTS RELATED TO THESE COMPONENTS (DELTA POLY LINER AND FEMORAL HEAD).

    Description of Event or Problem · 1

    THIS IS A REVISION OF A DELTA HIP PROSTHESIS. THE ORIGINAL SURGERY HAS BEEN PERFORMED ON (B)(6) 2013. THEN THE PT SUFFERED AN INFECTION IN THE JOINT. IT WAS AN INFECTION CAUSED BY (B)(6). THE REVISION SURGERY HAS BEEN PERFORMED ON (B)(6) 2013; THE SURGEON REMOVED THE COCRMO FEMORAL HEAD AND THE DELTA POLY LINER, LEAVING IMPLANTED THE FEMORAL STEM AND THE DELTA TT CUP. THE EVENT OCCURRED IN (B)(6) AND WAS REPORTED TO LIMACORPORATE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204770 DELTA POLY LINER, I.D. 36MM, #L LPH, MBL LPH LIMACORPORATE S.P.A. 5886.51.260 201300493-1300025

    Patients

    Seq Age Sex Outcome Treatment
    1 N/K Required Intervention FEMORAL HEAD DIA. 36 MM #L (COCRMO)