BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECCENTRICAL ADAPTOR TAPE, +4MM, STANDARD

    MDR report key: 3349723 · Received September 3, 2013

    Report

    Report Number
    3008021110-2013-00019
    Event Type
    Other
    Date Received
    September 3, 2013
    Date of Event
    July 22, 2013
    Report Date
    September 3, 2013
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE DHR OF THE COMPONENTS WHOSE CONNECTION FAILED (HUMERAL BODY AND ADAPTOR TAPER), WITHOUT FINDING ANY DIMENSIONAL ANOMALY ON THEM. WE ALSO VERIFIED THAT A TOTAL OF 21 HUMERAL BODIES AND 26 ADAPTOR TAPERS WITH THE BATCHES INVOLVED IN THIS EVENT HAVE BEEN IMPLANTED, WITHOUT RECEIVING ANY OTHER SIMILAR SIGNALING. A MEDICAL JUDGMENT ON THE AVAILABLE X-RAYS, DATED (B)(6) 2013 AND (B)(6) 2013, STATED THAT THE PT ((B)(6) FEMALE) SUFFERS AN IMPORTANT CUFF ARTHROPATHY, AND THERE IS NO GLENOID BONE LEFT. IT ALSO STATED THAT AN INSUFFICIENT MORSE TAPER FIXATION BETWEEN THE HUMERAL BODY AND THE ADAPTER TAPER DUE TO A SURGICAL ERROR IS POSSIBLE. THE VERY EARLY ROTATION OF THE ADAPTOR TAPER ONTO THE HUMERAL BODY SUGGESTS THAT THE COMPONENTS WERE NOT COUPLED PROPERLY DURING THE ORIGINAL SURGERY. THE DATE OF THE REVISION SURGERY IS STILL TO BE PLANNED, AS THE PT IS NOT COMPLAINING OF ANYTHING AT THE MOMENT. SHOULD WE RECEIVE FURTHER INFO ON THIS EVENT (EXPLANTS, FURTHER X-RAYS) WE WILL SUBMIT AN ADDITIONAL REPORT. THIS IS THE 1ST CASE REPORTED OF ROTATION (WITHOUT DISASSEMBLY) OF THE ADAPTOR TAPER ON THE HUMERAL BODY. WE ARE AWARE OF 2 OTHER CASES, WHERE AN EARLY DISASSEMBLY BETWEEN THE ADAPTOR TAPER AND THE HUMERAL BODY OCCURRED. OUR ANALYSIS ON ONE OF THESE DISASSEMBLIES SHOWED THE DIMENSIONAL COMPLIANCE OF THE DEVICES TO THE SPECIFICATIONS, WHILE IN THE 2ND CASE A DEEP ANALYSIS WAS NOT POSSIBLE. A TOTAL OF ABOUT (B)(4) IMPLANTS OF SMR ANATOMIC PROSTHESIS HAVE BEEN PERFORMED WORLDWIDE SINCE 2002, SO THE OCCURRENCE RATE CONSIDERING ALL THE 3 CASES IS (B)(4) BUT, BY OUR ANALYSIS, THE OCCURRENCE RATE "PRODUCT-RELATED" IS CURRENTLY 0.

    Description of Event or Problem · 1

    THIS IS AN INCIDENT DUE TO MOBILIZATION OF AN SMR SHOULDER ANATOMIC PROSTHESIS, OCCURRED IN (B)(6). THE PT HAD THE ORIGINAL SURGERY PERFORMED ON (B)(6) 2013: DURING THIS SURGERY, THE SURGEON IMPLANTED A LIMA SMR ANATOMIC HEMI PROSTHESIS (STEM, HUMERAL BODY, ADAPTOR TAPER AND HUMERAL HEAD). WE RECEIVED X-RAYS DATED (B)(6) 2013 AND (B)(6) 2013: CONSIDERING THESE TWO X-RAYS, THERE IS A CHANGE OF THE POSITON OF THE HUMERAL HEAD WITH REGARDS TO THE HUMERAL BODY, MEANING THAT THE ADAPTOR TAPER (FIRMLY FIXED TO THE HUMERAL HEAD AND DIRECTLY CONNECTED TO THE HUMERAL BODY) ROTATED ONTO THE HUMERAL BODY. THE REVISION SURGERY HAS NOT BEEN PERFORMED YET; THEREFORE, THE DEVICES ARE STILL "IN VIVO". CURRENTLY , NO ADVERSE EVENT OF PT IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436545 ECCENTRICAL ADAPTOR TAPE, +4MM, STANDARD KWT, HSD KWT LIMACORPORATE S.P.A. 1330.15.274 201212146

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention HUMERAL BODY (MODEL # 1350.15.010,| LOT # 201301527)