BEUDAMED
    FDA Adverse Event Other Summary report: N

    DELTA TT CUP, DIA.56 MM

    MDR report key: 3229810 · Received July 4, 2013

    Report

    Report Number
    3008021110-2013-00010
    Event Type
    Other
    Date Received
    July 4, 2013
    Date of Event
    May 27, 2013
    Report Date
    July 4, 2013
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE 1ST SIMILAR CASE REPORTED TO LIMACORPORATE. WE CHECKED THE DHR OF THE DELTA TT CUP INVOLVED, WITHOUT FINDING ANY ANOMALY WHICH COULD HAVE CAUSED THE PRESENCE OF A SHAVING ON THE CUP EXTERNAL SURFACE. AT THE MOMENT, WE RECEIVED A PHOTO OF THE CUP INVOLVED, WHICH SHOWS THE PRESENCE OF THE SHAVING ON THE POLAR PART OF THE CUP EXTERNAL SURFACE. BASED ON THIS PHOTO, IT APPEARS THAT THE SHAVING COULD COME FROM THE MACHINING PROCESS OF THE CUP. WE WILL ALSO RECEIVE THE CUP, THEREFORE, WE WILL SUBMIT A FOLLOW-UP REPORT AFTER ANALYSIS ON IT.

    Description of Event or Problem · 1

    THIS IS AN INTRA-OPERATIVE ISSUE, OCCURRED IN (B)(6). THE DELTA TT CUP WAS OPENED IN THEATRE, AND FOUND TO HAVE WHAT LOOKED LIKE A HAIR BUT ON CLOSER EXAMINATION IT APPEARS TO BE FINE SHAVINGS ON ITS EXTERNAL SURFACE. THERE WAS NO PATIENT INVOLVEMENT, AS THE SHAVING WAS EASILY IDENTIFIED, AND THE CUP HAS NOT BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306671 DELTA TT CUP, DIA.56 MM LPH, MBL LPH LIMACORPORATE S.P.A. 5552.15.560 201304062

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization