BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 2930363 · Received January 22, 2013

    Report

    Report Number
    9613350-2013-01279
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    July 18, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN 07/2008. 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. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED OUT OF THE USE OF A DUROM HIP GENERIC. IT HAS BEEN REPORTED THAT THE PT RECEIVED A DUROM HIP GENERIC ON (B)(6) 2007 AND UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO UNK REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30217 DUROM ACETABULAR COMPONENT DUROM US ACETABULAR COMPONENT 56/50 P LZO ZIMMER GMBH 2349680

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Hospitalization| R