BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM HIP GENERIC

    MDR report key: 2891216 · Received December 13, 2012

    Report

    Report Number
    9613350-2012-01163
    Event Type
    Other
    Date Received
    December 13, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 18, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AS THE PT HAS NOT BEEN REVISED. AS NO LOT NUMBER WAS PROVIDED FOR THE DEVICE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE 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 AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED A DURON HIP GENERIC IN (B)(6) 2006 ON THE LEFT HIP. A REVISION SURGERY IS SCHEDULED DUE TO ONGOING NON-DISABLING SYMPTOMS, WHICH HAVE RECENTLY ESCALATED, A LOOSE ACETABULAR, PAIN AND INCREASED COBALT LEVELS TO 7.5. SINCE THE EXACT DATE OF SURGERY IS UNKNOWN, WE ENTER THE FIRST DAY OF THE MONTH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other