BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTRUDED POLY LINER FOR DELTA HIP PROSTHESIS

    MDR report key: 3851182 · Received March 18, 2014

    Report

    Report Number
    3008021110-2014-00006
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    January 15, 2014
    Report Date
    February 18, 2014
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE WORK CYCLE OF THE DELTA POLY LINER INVOLVED, WITHOUT FINDING ANY DIMENSIONAL ANOMALY ON THE (B)(4) PIECES WITH THIS LOT NUMBER (201302994) RELEASED ON THE MARKET. BY OUR CHECKS, (B)(4) OF THESE LINERS HAVE BEEN IMPLANTED WITHOUT RECEIVING ANY OTHER SIGNALING. THE LINER INVOLVED IS BEING RETURNED TO US, THEREFORE, WE WILL SUBMIT A FOLLOW-UP MDR AFTER RECEIVING AND ANALYZING IT.

    Description of Event or Problem · 1

    DURING A HIP SURGERY DATED (B)(6) 2014, AFTER INSERTION OF THE DELTA POLY LINER PROTRUDED (DEVICE MARKETED IN THE U.S.) INTO A DELTA PF ACETABULAR CUP (DEVICE NOT MARKETED IN THE U.S.), THE POLY LINER DID NOT FIND A STABLE CONICAL COUPLING INSIDE THE CUP. IN DETAIL, IT WAS REPORTED THAT "THE POLY LINER ROTATED INSIDE THE CUP AFTER IMPACTION." THE EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159851 PROTRUDED POLY LINER FOR DELTA HIP PROSTHESIS LPH, MBL LPH LIMACORPORATE S.P.A. 5886.51.160 201302994

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DELTA PF CUP (NOT MARKETED IN THE U.S.)