BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 54/48 CODE N

    MDR report key: 3962584 · Received July 14, 2014

    Report

    Report Number
    9613350-2014-03718
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 7, 2013
    Report Date
    June 17, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008 AS REFERENCED. 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. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. ZIMMER'S REF NUMB OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REOPENED ON FEBRUARY 21, 2017 TO ENTER ADDITIONAL INFORMATION WHICH WAS RECEIVED ON FEBRUARY 15, 2017. WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008. 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. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008, ZIMMER (B)(4) WILL CLOSE THIS CASE ONCE AGAIN. (B)(4).

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT A PRODUCT LIABILITY CLAIM WAS RAISED. THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 54/48 CODE N. THE PATIENT WAS REVISED DUE TO PAIN, LOOSENING, TISSUE REACTION, ELEVATED METAL IONS, CYST FORMATION AND FLUID COLLECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM US ACETABULAR COMPONENT 54/48 N ON THE LEFT SIDE ON (B)(6) 2007. THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409769 DUROM ACETABULAR COMPONENT 54/48 CODE N DUROM ACETABULAR COMPONENT AND METASUL LDH KWA ZIMMER GMBH N/A 2349668

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R