BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM HIP

    MDR report key: 2933204 · Received January 9, 2013

    Report

    Report Number
    9613350-2013-01233
    Event Type
    Other
    Date Received
    January 9, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWY
    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 PT IS MONITORED AND HAS NOT BEEN REVISED TO DATE. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. AS THE PT HAS NOT BEEN REVISED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE WILL BE TREATED AS A CASE WHICH IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN (B)(4) 2008. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICES BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE MADE 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).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PT RECEIVED A DUROM HIP GENERIC ON THE LEFT SIDE ON (B)(6) 2008 AND IS BEING MONITORED DUE TO PAIN AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12956 DUROM HIP DUROM HIP GENERIC KWY ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other