BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 56/50 P

    MDR report key: 3032739 · Received March 8, 2013

    Report

    Report Number
    9613350-2013-01403
    Event Type
    Other
    Date Received
    March 8, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 IS MONITORED AND HAS NOT BEEN REVISED TO DATE. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES AND 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 DATE OF THE ORIGINAL IMPLANTATION SUGGESTS THAT THIS CASE MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JUL 2008. 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

    A PRODUCT LIABILITY CLAIM WAS RAISED OUT OF THE USE OF A DUROM ACETABULAR COMPONENT. IT WAS REPORTED THAT THE PT RECEIVED A DUROM US ACETABULAR COMPONENT 56/50 P ON THE RIGHT SIDE ON (B)(6) 2007 AND IS BEING MONITORED DUE TO UNK SYMPTOMS. IN THIS REPORT SUPPLEMENTAL INFO IS SUBMITTED FOR AN EXISTING BUT NOT IDENTIFIED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100656 DUROM US ACETABULAR COMPONENT 56/50 P DUROM US ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2337798

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other