BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 52/46 L

    MDR report key: 3240416 · Received July 18, 2013

    Report

    Report Number
    9613350-2013-01737
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    January 17, 2013
    Report Date
    October 23, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND 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 REFERENCED ABOVE. AN UPDATED REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS RECEIVED OR THE PRODUCT IS RETURNED FOR INVESTIGATION AND THE RESULT BECOMES AVAILABLE. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. ZIMMER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    THE PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF THE DUROM ACETABULAR CUP. IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT RECEIVED AN IMPLANT ON (B)(6) 2007 AND WAS REVISED ON (B)(6) 2013. THIS IS A BILATERAL CLAIMANT. PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ADDITIONAL INFORMATION: LEFT HIP SURGERY IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336530 DUROM US ACETABULAR COMPONENT 52/46 L DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH NA 2392563

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Hospitalization| R