BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 50/44 CODE J

    MDR report key: 3240377 · Received July 18, 2013

    Report

    Report Number
    9613350-2013-01744
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    January 30, 2013
    Report Date
    November 21, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    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 MFR DID NOT RECEIVE 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. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. SHOULD ADD'L INFO BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. A TIGHT MONITORING IS ONGOING FOR REVISIONS WITH EU DUROM CUPS WHERE THE INITIAL IMPLANT DATE OCCURRED AFTER THE ACCOMPLISHMENT OF A RETRAINING PROGRAM FOR USERS OUTSIDE THE U.S. WHICH WAS INITIATED IN NOVEMBER 2009 AS A CORRECTIVE ACTION AND REPORTED TO THE (B)(4) AS REQUIRED. THE DUROM CUP REPORTED IN THIS CASE IS NOT MARKETED IN THE U.S. A SIMILAR CUP, COMPATIBLE WITH THE METASUL LDH FEMORAL HEAD, IS CLEARED IN THE U.S., AND A CORRECTIVE ACTION FOR THIS PRODUCT WAS REPORTED TO THE FDA IN V 2008 AS CORRECTION Z-2415/2426-2008. 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 PT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF A DUROM ACETABULAR CUP. IT WAS REPORTED THAT THE PT RECEIVED A DUROM ACETABULAR COMPONENT 50/44 CODE J ON (B)(6) 2010 AND UNDERWENT REVISION SURGERY ON (B)(6) 2013 DUE TO PAIN, LOOSENING AND WEAR. "AT REVISION PREMATURE WEAR OF THE SURROUNDINGS TISSUES AND OF THE PROSTHESIS WAS NOTED AND SHE WAS REQUIRED TO RECEIVE BONE GRAFT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336129 DUROM ACETABULAR COMPONENT 50/44 CODE J DUROM ACETABULAR COMPONENT AND METASUL LDH KWA ZIMMER GMBH N/A 2448059

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R