BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 54/48 N

    MDR report key: 2880965 · Received December 13, 2012

    Report

    Report Number
    9613350-2012-01156
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD BEEN IMPLANTED WITH A DUROM ACETABULAR COMPONENT AND A DUROM FEMORAL COMPONENT TO WHICH THE COMBINATION OF THESE DEVICES ARE NOT ALLOWED IN THE US. THEREFORE, THIS IS AN OFF-LABEL USE COMPLAINT AND THERE WILL BE NO FURTHER INVESTIGATION TO BE CONDUCTED BY ZIMMER (B)(4). THIS CASE IS CONSIDERED AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008, ZIMMER GMBH WILL CLOSE THIS CASE ONCE AGAIN. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT RECEIVED A DUROM ACETABULAR COMPONENT 54/48 N AND DUROM FEMORAL COMPONENT 48 CODE NON (B)(6) 2008, RIGHT SIDE. THE PATIENT IS CURRENTLY BEING MONITORED DUE TO PAIN.

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. CURRENTLY, THE PATIENT IS BEING MONITORED DUE TO PAIN AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT 54/48 N DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2435696

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other