BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A.S. HUMERAL STEM REV. 9 CEMENTED

    MDR report key: 2012527 · Received February 24, 2011

    Report

    Report Number
    9613350-2011-00090
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    May 18, 2006
    Report Date
    January 25, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGERY WAS RELATED TO THE FOLLOWING STUDY: ANATOMICAL SHOULDER INVERSE/REVERSE POST MARKET SURVEILLANCE STUDY (B)(6). THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE EXPLANTED DEVICES, THE DEVICES HISTORY RECORD COULD NOT BE REVIEWED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN EMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PROXIMAL HUMERUS FRACTURED DURING IMPLANTATION OF THE HUMERAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A.S. HUMERAL STEM REV. 9 CEMENTED SULZER ORTHOPEDICS ANATOMICAL SHOULDER HSD ZIMMER GMBH 2286348

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other