BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIGLIANI/FLATOW HUMERAL STEM

    MDR report key: 4223432 · Received October 29, 2014

    Report

    Report Number
    1822565-2014-01492
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ZIMMER INC
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER NO INFORMATION HAS BEEN RECEIVED TO DATE. WITH THE SUPPLIED INFORMATION AN EXACT CAUSE CANNOT BE DETERMINED AT THIS TIME. EVALUATION: IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY CODES WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS WERE UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT RADIOGRAPHIC EVALUATION REVEALED THE PATIENT'S HUMERAL COMPONENT HAD LUCENT LINES OF 2 MM OR MORE IN ZONES 4, 5, AND 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692610 UNKNOWN BIGLIANI/FLATOW HUMERAL STEM SHOULDER PROSTHESIS HSD ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other