BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABLILAR COMPONENT 48/42 H

    MDR report key: 3830173 · Received March 26, 2014

    Report

    Report Number
    9613350-2014-03401
    Event Type
    Injury
    Date Received
    March 26, 2014
    Date of Event
    April 19, 2013
    Report Date
    February 27, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED, FROM THE INFO 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 ABOVE. SHOULD ADD'L INFO 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. THEREFORE, ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE PT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF THE DUROM ACETABULAR CUP. IT WAS REPORTED THAT SHE RECEIVED A DUROM ACETABULAR COMPONENT ON RIGHT SIDE ON (B)(6) 2007 AND WAS REVISED ON (B)(6) 2013 DUE TO PAIN AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176300 DUROM US ACETABLILAR COMPONENT 48/42 H DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2357530

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R