BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK CERASUL INLAY

    MDR report key: 3970994 · Received July 8, 2014

    Report

    Report Number
    9613350-2014-03696
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 25, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT YET RECEIVED THE DEVICE, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS THE LOT NUMBER WAS NOT PROVIDED FOR THE DEVICE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT WAS IMPLANTED ON THE LEFT SIDE WITH A CERASUL INLAY (EXACT CATALOGUE NUMBER UNKNOWN) SOMETIME IN 2003 (EXACT DATE UNK) AND WAS EXPLANTED ON (B)(6) 2014 DUE TO PAIN AND DISLOCATION OF THE CERSAUL INLAY. IT IS ALSO REPORTED, THE INCIDENT (DISLOCATION OF THE INLAY) OCCURRED APPROXIMATELY 4 WEEKS (EXACT DATE UNKNOWN) PRIOR TO THE PERFORMED REVISION SURGERY AND THAT THE CERAMIC PART HAS NOT BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397862 UNK CERASUL INLAY UNK CERASUL INLAY KWA ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R