BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A.S. HUMERAL STEM 14 UNCEMENTED

    MDR report key: 3445284 · Received October 29, 2013

    Report

    Report Number
    9613350-2013-01980
    Event Type
    Injury
    Date Received
    October 29, 2013
    Date of Event
    September 16, 2013
    Report Date
    September 19, 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

    THIS PATIENT WAS INITIALLY REPORTED TO HAVE 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 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 WERE REMOVED AND REPLACED. (REF NUMBER OF THE REPORT IS (B)(4)). THE REPORT OF THE REMOVAL OF THE SCREWS, THE BASE PLATE (EXT-TMR-IMP-GLE), AND THE GLENOSPHERE (EXT-TMR-IMP-HED-GLE) WERE REPORTED TO YOUR OFFICE BY ZIMMER WARSAW AS THEY ARE THE DESIGN CONTROL OWNER OF THESE DEVICES. COMPLAINT NUMBER IS (B)(4). 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. ZIMMER REFERENCE NUMBER OF THIS CASE IS (B)(4).

    Description of Event or Problem · 1

    THIS PATIENT WAS REPORTED TO HAVE ANOTHER COMPLETE DETACHMENT OF THE GLENOSPHERE. DURING THE FOLLOWING POST-OPERATIVE X-RAY PERFORMED ON (B)(6) 2013, IT HAS BEEN OBSERVED THAT THE GLENOSPHERE COMPLETELY DETACHED ONCE AGAIN. THE PATIENT WAS MOVED TO ANOTHER HOSPITAL WHERE UPON ON (B)(6) 2013, HE HAD TO UNDERGO A SECOND REVISION SURGERY TO REMOVE ALL THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554806 A.S. HUMERAL STEM 14 UNCEMENTED ANATOMICAL SHOULDER STEM HSD ZIMMER GMBH 2704229

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R