BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM U.S. ACETABULAR COMPONENT 54/48 N

    MDR report key: 2925098 · Received January 17, 2013

    Report

    Report Number
    9613350-2013-01268
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    August 27, 2012
    Report Date
    December 31, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PT HAS NOT BEEN REVISED TO DATE. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. AS THE PT HAS NOT BEEN REVISED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. SHOULD ADDITIONAL INFO 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 FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RATED OUT OF THE USE OF A DUROM U.S. ACETABULAR COMPONENT. IT IS REPORTED THAT THE PT RECEIVED A DUROM U.S. ACETABULAR COMPONENT 54/48 N ON THE RIGHT SIDE OF (B)(6) 2006 AND UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO PAIN, LOOSENING AND ELEVATED COBALT LEVELS IN BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26248 DUROM U.S. ACETABULAR COMPONENT 54/48 N DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2320669

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R