BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER HUMERAL STEM SIZE 12

    MDR report key: 3445285 · Received October 29, 2013

    Report

    Report Number
    9613350-2013-01982
    Event Type
    Injury
    Date Received
    October 29, 2013
    Date of Event
    September 16, 2013
    Report Date
    September 16, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE THE AFFECTED DEVICE, THE X-RAY (S), NOR OTHER SOURCE DOCUMENTS FOR REVIEW. THE CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, AN UPDATED REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS RECEIVED OR IF THE DEVICE IS RETURNED FOR INVESTIGATION AND THE RESULT BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT RECEIVED A REVERSE SHOULDER REPLACEMENT SURGERY ON (B)(6) 2013, ON HIS RIGHT SHOULDER. THIS SURGERY COMPOSES THE IMPLANTATION OF 2 COMPONENTS: THE GLENOSPHERE COMPONENTS WHICH ARE COMPOSED OF THE TM REVERSE BASEPLATE (EXT-TMR-IMP-GLE) AND THE TM REVERSE GLENOSPHERE (EXT-TMR-IMP-HED-GLE) WITH THEIR ASSOCIATED SCREWS (INVERSE/REVERSE SCREW SYSTEM). HUMERAL COMPONENTS WHICH ARE COMPOSED OF THE STEM (A.S. HUMERAL STEM), THE CUP (INVERSE HUMERAL CUP), AND THE INLAY (AS INVERSE HUMERAL PE-INLAY). A DAY LATER ((B)(6) 2013), ON A POST-OPERATIVE X-RAY, THE RESULT EMPHASIZED THE COMPLETE DETACHMENT OF THE GLENOSPHERE. HENCE THE PATIENT HAD TO UNDERGO REVISION SURGERY ON (B)(6) 2013, WHEREUPON THE SURGEON RE-ASSEMBLED THE BASEPLATE AND THE GLENOSPHERE BUT THE STEM 12, THE CUP AND THE IN-LAY 40-0 WHERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554087 ANATOMICAL SHOULDER HUMERAL STEM SIZE 12 ANATOMICAL SHOULDER WITH REMOVABLE HEAD HSD ZIMMER GMBH 2664669

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R