BEUDAMED
    FDA Adverse Event Death Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 4941997 · Received July 23, 2015

    Report

    Report Number
    9613350-2015-00821
    Event Type
    Death
    Date Received
    July 23, 2015
    Date of Event
    July 13, 2014
    Report Date
    June 30, 2015
    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 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, 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 NOTIFICATION IN (B)(6) 2008 AS REFERENCED ABOVE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BECOME 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'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT ON AN UNKNOWN SIDE ON (B)(6) 2008. PATIENT HAD GONE TO HIS DOCTOR FOR AN EVALUATION, BUT WAS TOLD THERE WAS NO ISSUE WITH THE HIP THAT THE RECALL COVERED. IN THE EVALUATION DOCTOR FOUND THE HIP WAS NOT COMING OUT OF THE JOINT AND IT WAS NOT FAILING ALSO. THEN DOCTOR TOLD NO NEED FOR ANY REVISION SURGERY. BLOOD TEST WAS TAKEN FOR SUBSEQUENT YEARS FROM 2012 TO 2014. IT WAS FOUND TO BE HIGH METAL LEVELS IN BLOOD. THE PATIENT COMMITTED SUICIDE BECAUSE OF DEPRESSION, PAIN AND HIS INABILITY TO CONCENTRATE AND THINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478322 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death