BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A.S. HUMERAL STEM 12 UNCEMENTED

    MDR report key: 3940401 · Received June 18, 2014

    Report

    Report Number
    9613350-2014-03623
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVED YET THE DEVICES, BUT IT IS MENTIONED BY COMPLAINANT THAT THE DEVICES WILL BE PROVIDED FOR INVESTIGATION. OTHER SOURCE DOCUMENTS (X-RAYS, SURGICAL REPORTS) WERE NOT YET PROVIDED FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2014 THAT APPROXIMATELY ONE YEAR AGO (EXACT DATE OF IMPLANT UNK) A ANATOMICAL SHOULDER PROSTHESIS WAS IMPLANTED. THEN, THE SURGEON DECIDED TO CONVERT THE ANATOMICAL SHOULDER IMPLANT TO AN INVERSE SYS (THE REASON FOR REVISION WAS INSUFFICIENT ROTATOR CUFF RESULTED IN DISLOCATION OF HUMERUS) ON (B)(6) 2014. DURING THE REVISION, THE SURGEON WAS NOT ABLE TO REMOVE THE CONICAL HEAD FROM THE SHAFT. THEREFORE, THE SURGEON HAD TO REMOVE AND CHANGE THE ENTIRE PROSTHESIS (SHAFT INCLUDED), HE WAS NOT ABLE TO CHANGE THE SYS ACCORDING TO THE SURGICAL TECHNIQUE AS IT WAS PRIMARILY PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357605 A.S. HUMERAL STEM 12 UNCEMENTED ANATOMICAL SHOULDER WITH REMOVABLE HEAD LZO ZIMMER GMBH NA 2631899

    Patients

    Seq Age Sex Outcome Treatment
    1 Other