BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 54/48 CODE N

    MDR report key: 3221530 · Received July 9, 2013

    Report

    Report Number
    9613350-2013-01708
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    July 23, 2007
    Report Date
    June 28, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. OTHER SOURCE DOCUMENTS (SURGICAL REPORT) WERE PROVIDED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REOPENED ON JANUARY 19, 2017 TO ENTER ADDITIONAL INFORMATION WHICH WAS RECEIVED ON JANUARY 18, 2017. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION WHICH WAS REPORTED TO THE FDA IN JULY 2008 AS CORRECTION Z-2415/2426-2008, THERE WILL BE NO FURTHER INVESTIGATION AND ZIMMER (B)(4) WILL CLOSE THIS CASE ONCE AGAIN. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 54/48 CODE N ON THE RIGHT SIDE ON AN UNKNOWN DATE. ON (B)(6) 2007, DUE TO PAIN IN THE RIGHT HIP, THE PATIENT UNDERWENT AN INVESTIGATION SURGERY WITH RELEASE OF THE PSOAS MUSCLE. THE IMPLANT WAS NOTED AS STABLE. ON (B)(6) 2009, THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN AND LOOSENING.

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 54/48 CODE N ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312845 DUROM ACETABULAR COMPONENT 54/48 CODE N DUROM ACETABULAR COMPONENT AND METASUL LDH KWA ZIMMER GMBH N/A 2364700

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R