BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 50/44 J

    MDR report key: 3032733 · Received March 12, 2013

    Report

    Report Number
    9613350-2013-01414
    Event Type
    Other
    Date Received
    March 12, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 26, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE THE PRODUCTS SINCE THE PT HAS NOT BEEN REVISED TO DATE. WHERE LOT NUMBERS WERE RECEIVED FOR THE 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 SUGGESTS THAT THIS CASE MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008 AS REFERENCED. SHOULD ADD'L 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 AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED A DUROM US ACETABULAR COMPONENT 50/44 J ON (B)(6) 2006 AND IS CURRENTLY BEING MONITORED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104598 DUROM US ACETABULAR COMPONENT 50/44 J DUROM US ACETABULAR COMPONENT KWA ZIMMER GMBH 2325889

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other