BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANATOMICAL SHOULDER HUMERAL STEM SIZE 7

    MDR report key: 3202111 · Received June 24, 2013

    Report

    Report Number
    9613350-2013-01662
    Event Type
    Other
    Date Received
    June 24, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVED DEVICES OR OTHER SOURCE DOCUMENTS FOR REVIEW; HENCE, THE CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER REF NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE VERSION OF THE A.S. HUMERAL HEAD (D44 H16) DID NOT SEAT PROPERLY ON THE STEM (A.S. HUMERAL STEM 7, CEMENTLESS). SEVERAL ATTEMPTS WERE MADE TO DISENGAGE THE HEAD FROM THE STEM. THE SURGEON, INSTEAD, DECIDED TO REMOVE THE STEM TO TRY AND REMOVE THE BALL TAPER BUT WAS UNSUCCESSFUL. AT THE END, THE SURGEON DECIDED TO CEMENT A 7MM STEM AND THE SURGERY WAS EXTENDED BY ANOTHER 31-60 MINUTES. NO HARM CAME UPON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284633 ANATOMICAL SHOULDER HUMERAL STEM SIZE 7 ANATOMICAL SHOULDER WITH REMOVABLE HEAD HSD ZIMMER GMBH 2649290

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other