BEUDAMED
    FDA Adverse Event Other Summary report: N

    A.S. HUMERAL UNCEMENTED STEM 14

    MDR report key: 1692171 · Received May 12, 2010

    Report

    Report Number
    9613350-2010-00220
    Event Type
    Other
    Date Received
    May 12, 2010
    Date of Event
    April 8, 2010
    Report Date
    April 12, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. PATIENT: SURGERY PROLONGATED BY 30 TO 45 MINUTES. DEVICE: DID NOT FUNCTION PROPERLY. THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED, NO TREND COULD BE IDENTIFIED. 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 FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4). ADDITIONAL INFORMATION: 5:00 AM.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGERY WAS DELAYED (FIXATION OF THE BALL TEMPER) DUE TO HANDLING PROBLEMS WITH THE DEVICE BY 30 TO 45 MINUTES. NO FURTHER ADVERSE EVENT WAS REPORTED. THE DEVICES ARE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A.S. HUMERAL UNCEMENTED STEM 14 NONE HSD ZIMMER GMBH NA 2472008

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR