BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 54/48 CODE N

    MDR report key: 2871532 · Received December 6, 2012

    Report

    Report Number
    9613350-2012-01129
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    Z-2415/2426-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICE AND THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED AND A PRODUCT FAILURE CANNOT BE CONFIRMED. 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 NATIONAL COMPETENT AUTHORITIES 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 JULY 2008 AS CORRECTION Z-2415/2426-2008. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED A DUROM ACETABULAR COMPONENT 54/48 CODE N ON (B)(6) 2010 AND UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO HETEROTROPIC OSSIFICATION AND LEG-LENGTH DISCREPANCY. IT WAS ALSO NOTED THAT THERE WAS "OBVIOUS BLACK TISSUE AND STAINING AROUND THE TRUNNION OF THE FEMORAL STEM IMPLANT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT 54/48 CODE N DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2471848

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R