BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 11/13 32MM +6

    MDR report key: 3979287 · Received August 5, 2014

    Report

    Report Number
    1818910-2014-25001
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    May 28, 2014
    Report Date
    July 8, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINTS DATABASE AND MANUFACTURING RECORDS DID NOT IDENTIFY ANY ANOMALIES. A MANUFACTURING REVIEW AS CONDUCTED BY THE SUPPLIER AND NO ANOMALIES WERE IDENTIFIED.THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE PATIENT IS MALE AND (B)(6), HAD DDH, DID HIP REPLACEMENT AND IMPLANTED OUR DEVICE (CODE: 136532230, LOT NO. 3132425) ON (B)(6) 2011. THE PATIENT HAD DISLOCATION AFTER ONE MONTH. MANUAL RESET WAS GIVEN AT THAT TIME. AFTER HALF YEAR, THE PATIENT MET SAME PROBLEM. THE SURGEON HAD TO TAKE REVISION SURGERY IN YR 2012. REMOVED THE OLD DEVICE AND IMPLANTED NEW ONE (CODE: 136536240, LOT NO. 3112513). ON (B)(6) 2014, THE PATIENT HAD A SLIGHT FALL AS PER HIS DESCRIPTION. THUS THE DEVICE WAS BROKEN. THE SURGEON CALLED (B)(6) DID 2ND REVISION SURGERY (CODE: 136536240, LOT NO. 3112513, CODE: 121881762, LOT NO. 7812364) FOR THE PATIENT. THE REMOVED SAMPLES WERE RETAINED BY PATIENT FOR LEGAL PURPOSE. ADDITIONAL INFORMATION: THIS CASE HAS BEEN UPGRADED TO LEGAL CASE AND THE COURT WILL BEGIN ON (B)(6) 2014. THE PATIENT HAS INCLUDED US AS DEFENDANT. TEST REPORT WAS REQUIRED AND THE HOSPITAL REQUIRED THE LEGAL SUPPLIER TO ATTEND THE COURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456978 DELTA CER HEAD 11/13 32MM +6 HIP FEMORAL HEAD LZO DEPUY IRELAND 9616671 3132425

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other