BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM HIP

    MDR report key: 3240406 · Received July 18, 2013

    Report

    Report Number
    9613350-2013-01748
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE CAUSE OF THE REVISION WAS NOT REPORTED, BUT FROM THE INFO PROVIDED, ORIGINAL IMPLANTATION DATE SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008 AS REFERENCED ABOVE. 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

    THE PT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF THE DUROM ACETABULAR CUP WAS REPORTED BY PT'S COUNSEL THAT THE PT RECEIVED AN IMPLANT IN 2006 AND THAT HE WAS REVISED IN 2010 DUE TO UNK REASONS. NO SPECIFIC IMPLANT OR REVISION INFO HAS BEEN RECEIVED. FOR DATA ENTRY THE FIRST DAY OF THE FIRST MONTH OF THE REPORTED YEARS WILL BE ENTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333461 DUROM HIP DUROM HIP GENERIC KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R