BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM HIP

    MDR report key: 3221819 · Received July 9, 2013

    Report

    Report Number
    9613350-2013-01700
    Event Type
    Other
    Date Received
    July 9, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    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, AS THE PATIENT IS MONITORED AND HAS NOT BEEN REVISED TO DATE. SINCE IMPLANT DATE IS UNKNOWN, THE COMPLAINT WILL BE HANDLED AS A CASE PRIOR TO (B)(4). THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, AS THE PATIENT HAS NOT BEEN REVISED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF THE DUROM ACETABULAR CUP. IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT RECEIVED AN IMPLANT (EXACT DATE NOT REPORTED) AND IS BEING MONITORED DUE TO UNKNOWN REASON. SINCE IMPLANT DATE IS UNKNOWN, THE COMPLAINT WILL BE HANDLED AS A CASE PRIOR TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313779 DUROM HIP DUROM HIP GENERIC KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other