BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 48/42 CODE H

    MDR report key: 3213728 · Received July 3, 2013

    Report

    Report Number
    9613350-2013-01693
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    October 26, 2010
    Report Date
    June 28, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW. BASED ON AN EXTENSIVE INVESTIGATION OF EVENTS REPORTED FROM SEVERAL USER FACILITIES OUTSIDE THE U.S, ZIMMER IDENTIFIED THAT THE MOST PROBABLE CAUSE FOR THE OUTCOME OBSERVED WAS A LOOSE OR UNSTABLE CUP THAT RESULTED FROM USE OF SURGICAL TECHNIQUES NOT CONSISTENT WITH THE MFR'S RECOMMENDATIONS. AS A CORRECTIVE ACTION, A RETRAINING PROGRAM FOR USERS OUTSIDE THE U.S WAS INITIATED IN NOVEMBER 2009 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 JULY 2008 AS CORRECTION Z-2415/2426-2008. AT THIS TIME OF THIS REPORT THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. IF ADD'L INFO IS REC'D AND THE PRODUCT IS RETURNED FOR INVESTIGATION, UN UPDATED REPORT WILL BE SUBMITTED. (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 BY PT'S COUNSEL THAT THE PT RECEIVED A DUROM US ACETABULAR COMPONENT 48/42 CODE H, RIGHT SIDE ON (B)(6) 2007 AND WAS REVISED ON (B)(6) 2010 DUE TO METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303665 DUROM ACETABULAR COMPONENT 48/42 CODE H DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2362850

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R