BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANATOMICAL RASP FOR HUMERAL STEM 10.5

    MDR report key: 2971956 · Received February 19, 2013

    Report

    Report Number
    9613350-2013-01358
    Event Type
    Other
    Date Received
    February 19, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON "CALLED FROM THE OPERATING ROOM AND SAID THE NEW ANATOMIC BROACHES HE JUST RECEIVED WON'T IMPACT THE CONE IN THE BALL TAPER. THE SURGEON HAD TO GO TO AN AS COMBINED DUE TO THIS ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72723 ANATOMICAL RASP FOR HUMERAL STEM 10.5 ANATOMICAL SHOULDER TM COMBINED SYSTEM HSD ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other