BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS INVERSE HUMERAL CUP, STANDARD

    MDR report key: 3452649 · Received October 30, 2013

    Report

    Report Number
    9613350-2013-01993
    Event Type
    Injury
    Date Received
    October 30, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVED DEVICES OR X-RAYS FOR REVIEW. WHERE LOT NUMBER WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE CAUSE FOR THIS SPECIFIC EVENT CANTO 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 PT 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 40-0). A DAY LATER ((B)(6) 2013), ON A POST-OPERATIVE X-RAY, THE RESULT EMPHASIZED THE COMPLETE DETACHMENT OF THE GLENOSPHERE. HENCE THE PT HAD TO UNDERGO REVISION SURGERY ON (B)(6) 2013, WHEREBY 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
    556851 AS INVERSE HUMERAL CUP, STANDARD ANATOMICAL SHOULDER INVERSE/REVERSE HSD ZIMMER GMBH 2706293

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R