BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERASUL ALPHA INSERT NEUTRAL II/28

    MDR report key: 3940594 · Received June 25, 2014

    Report

    Report Number
    9613350-2014-03659
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    November 13, 2013
    Report Date
    June 9, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, AN UPDATED REPORT WILL BE SUBMITTED ONCE THE DEVICES ARE RETURNED FOR INVESTIGATION AND THE RESULT OF THE INVESTIGATION HAS BEEN MADE AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF AN UNKNOWN ZIMMER HIP GENERIC IMPLANTS. IT WAS REPORTED BY THE PATIENT'S COUNSEL THAT HIS CLIENT RECEIVED A WINTERTHUR HIP GENERIC IMPLANTS ON (B)(6), 2004. ACCORDING TO THE REPORT RECEIVED FROM THE PATIENT'S LAWYER, ON (B)(6), 2013, THERE WAS AN "EXPLOSION IMPLANT OF THE HIP PROSTHESIS". DUE TO BREAKAGE OF THE IMPLANT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6), 2013. THIRTEEN DAYS LATER, THE PATIENT HAD ANOTHER SURGERY TO REMOVE THE REST OF THE BROKEN PIECES OF THE IMPLANT. FURTHER ON, DUE TO THE PATIENT EXPERIENCING "ISSUES" RELATED TO THE "IMPLANTS" (EXACT DEVICE NAME NOT KNOWN), THE PATIENT UNDERWENT A SECOND REVISION SURGERY IN (B)(6) 2014. THE EXACT DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369718 CERASUL ALPHA INSERT NEUTRAL II/28 CERASUL ALPHA INSERT KWA ZIMMER GMBH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R