BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 2217354 · Received July 13, 2011

    Report

    Report Number
    9613350-2011-00462
    Event Type
    Other
    Date Received
    July 13, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    C9613350-07/15/2008-001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. SINCE NO LOT NUMBERS WERE RECEIVED FOR THE DEVICE RELATED TO THIS CASE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 JUL 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 MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. ZIMMER REF NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT EXPERIENCED RIGHT HIP PAIN. IN ADDITION, IT IS REPORTED THAT THE PT STATED THAT A DURUM PRODUCT WAS USED FOR THE HIP REPLACEMENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other