BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 52/46 L

    MDR report key: 3240806 · Received July 17, 2013

    Report

    Report Number
    9613350-2013-01734
    Event Type
    Other
    Date Received
    July 17, 2013
    Date of Event
    June 1, 2010
    Report Date
    July 8, 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 MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PT IS CURRENTLY MONITORED. 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 INFORMATION BECOME AVAILABLE AND/OR THE DEVICES BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE 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. (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PT REC'D A DUROM US ACETABULAR COMPONENT 52/46 L, RIGHT SIDE, ON (B)(6) 2007. ON (B)(6) 2013, THE PT HAD A HIP RELATED COMPLICATION ON OPERATIVE HIP. DUE TO ACETABULAR LOOSENING, THE PT IS CURRENTLY BEING MONITORED. ADD'L INFO: THE PT HAD BILATERAL HIP REPLACEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331816 DUROM US ACETABULAR COMPONENT 52/46 L DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2367588

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other