BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 50/44 J

    MDR report key: 2960800 · Received February 11, 2013

    Report

    Report Number
    9613350-2013-01341
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 28, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REOPENED ON OCTOBER 05, 2015 TO ENTER ADDITIONAL INFORMATION WHICH HAD BEEN RECEIVED ON SEPTEMBER 25, 2015. 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. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FIELD. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO PAIN,LOOSENING AND PSEUDOTUMOR .

    Description of Event or Problem · 1

    THE PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF A DUROM ACETABULAR CUP. IT WAS REPORTED THAT THE PATIENT RECEIVED A DUROM US ACETABULAR COMPONENT 50/44 J ON THE RIGHT SIDE ON (B)(6) 2007 AND UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59581 DUROM ACETABULAR COMPONENT 50/44 J DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2362870

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R