BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL ALPHA INSERT NEUTRAL KK/32

    MDR report key: 3060191 · Received April 11, 2013

    Report

    Report Number
    9613350-2013-01484
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, AS THE PATIENT HAS NOT BEEN REVISED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE (S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, WE WILL SUBMIT A FOLLOW UP REPORT. (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT RECEIVED A DURASUL ALPHA INSERT NEUTRAL KK/32, LEFT HIP ON (B)(6) 2003 AND IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154799 DURASUL ALPHA INSERT NEUTRAL KK/32 DURASUL ALPHA INSERT KWB ZIMMER GMBH 2091221

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R