BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM HIP

    MDR report key: 3110989 · Received May 9, 2013

    Report

    Report Number
    9613350-2013-01556
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    October 19, 2010
    Report Date
    April 17, 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 NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, 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 TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008 AS REFERENCED ABOVE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BECOMES AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT, THROUGH COUNSEL, IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE ALLEGED USE OF THE DUROM ACETABULAR COMPONENT. IT IS UNKNOWN AT THIS TIME IF THE HIP PRODUCT IS ACTUALLY THE DUROM CUP. PRODUCT WAS IMPLANTED ON (B)(6) 2006 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010, DUE TO UNKNOWN REASON. SAME PATIENT HAS (B)(4) FOR LEFT HIP SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202555 DUROM HIP DUROM HIP GENERIC KWA ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R