BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM HIP

    MDR report key: 3240007 · Received July 18, 2013

    Report

    Report Number
    9613350-2013-01742
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ZIMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHILE A CAUSE FOR REVISION WAS NOT REPORTED, THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008 AS REFERENCE ABOVE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) 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. ZIMMER REFERENCE NUMBER (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. IT WAS REPORTED BY PT'S COUNSEL THAT THE PT RECEIVED AN IMPLANT IN 2009 AND THAT SHE WAS REVISED IN 2010 DUE TO UNK REASONS. NO SPECIFIC IMPLANT OR REVISION INFORMATION HAS BEEN RECEIVED. FOR DATA ENTRY PURPOSES, THE FIRST DAY OF THE FIRST MONTH OF THE YEAR REPORTED WILL BE ENTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335636 DUROM HIP DUROM HIP GENERIC KWA ZIMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R