BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA TT CUP, DIA.64MM

    MDR report key: 4955619 · Received July 31, 2015

    Report

    Report Number
    3008021110-2015-00032
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    June 23, 2015
    Report Date
    July 1, 2015
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO PROVIDED BY THE SOURCE: "CHRONIC INFECTION BY (B)(6), CONFIRMED AT THE TIME OF EXPLANTATION. INFECTION ALREADY PRESENT IN 2013." EXPLANTS NOT RETURNED. PHOTOS OF EXPLANTS AND X-RAYS NOT AVAILABLE. NO ANOMALIES DETECTED BY CHECKING THE STERILIZATION CHARTS OF THE DEVICES INVOLVED. NO OTHER COMPLAINTS RECEIVED ON THESE LOT . DELTA TT CUP (ONLY PIECE INVOLVED MARKETED IN THE US): 7 PIECES MANUFACTURED WITH THIS LOT #. PROBABLE CAUSE OF INFECTION BY THE AVAILABLE INFO: PREDISPOSITION OF THE PATIENT (CHRONIC INFECTION, ALREADY PRESENT IN 2013). EVENT NOT DUE TO PROSTHESIS ITSELF. PMS DATA: REVISION RATE ASSOCIATED TO THIS EVENT (INFECTIONS / SEPTIC LOOSENING WITH DELTA TT CUP) IS 0.016%; BY OUR ANALYSIS, ALL THE EVENTS ARE NOT DUE TO THE DEVICE ITSELF. NO CORRECTIVE ACTIONS. LIMACORPORATE WILL KEEP THE MARKET.

    Description of Event or Problem · 1

    HIP PROSTHESIS INCLUDING DELTA TT CUP IMPLANTED ON (B)(6) 2013. REVISION SURGERY ON (B)(6) 2015 DUE TO PERIPROSTHETIC INFECTION. THE EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500047 DELTA TT CUP, DIA.64MM LPH - MBL LPH LIMACORPORATE S.P.A. 5552.15.640 200904136

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention