BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 54/48 N

    MDR report key: 2081325 · Received April 28, 2011

    Report

    Report Number
    9613350-2011-00254
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 12, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    C9613350-7/15/2008-001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE REVISION SURGERY IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN (B)(6) 2008. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURE IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT REVISION SURGERY DUE TO PAIN AFTER THA ((B)(4)). IT IS ALSO REPORTED THAT SHE HAD HIGH CHROMIUM SERUM LEVEL WHEN THE ACET. CUP WAS RETRIEVED AND THAT CUP WAS LOOSE AND THERE WAS NO BONY INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 54/48 N DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2348415

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O