BEUDAMED
    FDA Adverse Event Other Summary report: N

    A.S. HUMERAL STEM 10.5 UNCEMENTED

    MDR report key: 3919502 · Received June 11, 2014

    Report

    Report Number
    9613350-2014-03597
    Event Type
    Other
    Date Received
    June 11, 2014
    Date of Event
    May 16, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES AS THE PT HAS NOT BEEN REVISED. THREE X-RAYS HAVE BEEN RECEIVED FOR REVIEW, NO OTHER SOURCE DOCUMENTS WERE PROVIDED FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. SHOULD ADD'L INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. NOTE: 3 SEPARATE MDR FOR ALL IMPLANTED PRODUCTS WITH WINTERTHUR DESIGN WILL BE FILED, ALL WITH CASE NUMBER (B)(4). THERE ARE ALSO PRODUCTS IMPLANTED WITH WARSAW DESIGN, THESE PRODUCTS WILL BE REPORTED WITH ZIMMER CASE NUMBER (B)(4). ZIMMER REF NO: (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT WAS IMPLANTED WITH AN AS SHOULDER SYSTEM AND PART OF SHOULDER PSI PILOT STUDY-STUDY ID (B)(6). IT WAS ALSO REPORTED THAT PT SUFFERED A NEUROPLEXIA (NERVUS ULNARIS) OF THE LEFT HAND. THE SURGEON RATES THE EVENT TO BE MILD, NO ACTIONS WERE TAKEN REGARDING A TREATMENT, THUS THERE IS A MINOR IMPACT TO THE PT. NO REVISION SURGERY HAS TAKEN PLACE, NEITHER A REVISION SURGERY HAS BEEN PLANNED, THE DEVICES RESTED IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343688 A.S. HUMERAL STEM 10.5 UNCEMENTED ANATOMICAL SHOULDER WITH REMOVABLE HEAD KWS ZIMMER GMBH NA 2660852

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other