BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA INSERT ME NEUTRAL HH/28

    MDR report key: 2850058 · Received November 26, 2012

    Report

    Report Number
    9613350-2012-01095
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS NOT YET RECEIVED EXPLANTED DEVICES REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. HOWEVER THERE IS NO INDICATION FOR A PRODUCT FAILURE. 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 AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION TOOK PLACE BECAUSE THE METAL PART INSIDE THE ALPHA INSERT LOOSENED FROM THE OUTER PE PART OF THIS INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA INSERT ME NEUTRAL HH/28 NONE HSH ZIMMER GMBH 2057911

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R