BEUDAMED
    FDA Adverse Event Death Summary report: N

    COCR HEAD 28/ 0 'M' 12/14

    MDR report key: 5021063 · Received August 21, 2015

    Report

    Report Number
    9613350-2015-00987
    Event Type
    Death
    Date Received
    August 21, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 5, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DHR REVIEW RESULTS: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND WAS IDENTIFIED. COMPATIBILITY CHECK: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. REVIEW OF EVENT DESCRIPTION: THE PATIENT DIED SHORTLY AFTER SURGERY WHICH WAS DELAYED (<15MIN) BECAUSE THE SURGEON COULD NOT FIND THE MEDULLARY PLUG AND HAD TO TAKE ONE FROM AN OTHER MANUFACTURER. A COCR HEAD 28/ 0 'M' 12/14 HEAD HAS ALSO BEEN IMPLANTED. THE OTHER IMPLANTS (STEM CUP LINER) ARE ZIMMER (B)(6). PRODUCTS AND COVERED IN (B)(4) (SPLIT CASE). REVIEW OF OTHER INCOMING INFORMATION: NO OTHER SOURCE DOCUMENTS WERE PROVIDED FOR REVIEW. NO PRODUCT WAS AVAILABLE FOR INVESTIGATION. ROOT CAUSE ANALYSIS: IT CAN BE ASSUMED THAT THE COCR HEAD DID NOT HAVE ANY CORRELATION WITH THE DEATH OF THE PERSON SINCE THE CONDITION OF THE PATIENT STARTED TO DECLINE BEFORE THE HEAD WAS IMPLANTED. MOREOVER THE HEAD DOES NOT HAVE A CORRELATION WITH THE SURGERY DELAY SINCE THIS WAS A PROBLEM WITH THE MEDULLARY PLUG. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE ISSUES REPORTED ARE LISTED IN DFMEA. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E COCR HEAD 40MM 12/14 GR. M / 0) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A COCR HEAD 28/ 0 'M' 12/14 ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT CONDITION DECLINED SEVERAL TIMES DURING THE SURGICAL PROCEDURE AND THAT HE WAS RESUSCITATED BEFORE BEING SEWN UP. IT WAS REPORTED THAT THE PATIENT PASSED AWAY LATER ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553737 COCR HEAD 28/ 0 'M' 12/14 UNKNOWN LPH ZIMMER GMBH NA 2806214

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death