BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM HIP GENERIC

    MDR report key: 2961840 · Received February 11, 2013

    Report

    Report Number
    9613350-2013-01340
    Event Type
    Other
    Date Received
    February 11, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWB
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PATIENT IS MONITORED AND HAS NOT BEEN REVISED TO DATE. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS THE PATIENT HAS NOT BEEN REVISED, THE DATE OF THE ORIGINAL IMPLANTATION SUGGESTS THAT THIS CASE MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008 AS REFERENCED. SHOULD ADDITIONAL INFORMATION BECAME 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A DUROM HIP GENERIC ON THE RIGHT SIDE ON (B)(6) 2007 AND IS BEING MONITORED DUE TO PAIN AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59568 DUROM HIP GENERIC DUROM HIP KWB ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other