BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZNN TRAUMA IMPLANT

    MDR report key: 3772229 · Received March 31, 2014

    Report

    Report Number
    9613350-2014-03417
    Event Type
    Other
    Date Received
    March 31, 2014
    Date of Event
    December 11, 2013
    Report Date
    March 12, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES AND X-RAYS AS THE PRODUCT IS STILL IMPLANTED. OTHER SOURCE DOCUMENTS (SURGICAL REPORT) WERE RECEIVED. AS NO LOT NUMBER WERE PROVIDE FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO 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 DURING SURGERY ON (B)(6) 2013, IT WAS NOT POSSIBLE TO EXPLANT THE FEMORAL NECK SCREW (RIGHT SIDE). THE FORM FIT BETWEEN FEMORAL NECK SCREW AND SETTING INSTRUMENT COULD NOT RESIST THE TORQUE FORCES. THE LAG SCREW WAS FRACTURED DURING REMOVAL. ON THE SUPPORTING DOCUMENTS IT IS ALSO MENTIONED: "DURING SURGERY THE NAIL CAP, SET SCREW AND DISTAL LOCKING SCREW WERE REMOVED. IT WAS NOT POSSIBLE TO REMOVE THE LAG SCREW AND THEREFORE THEY COULD NOT REMOVE THE NAIL AS WELL. THEY TRIED SEVERAL TIMES TO REMOVE THE LAG SCREW BUT IT DIDN'T WORK AND THEY SHEARED OFF THE TWO PARTS OF THE LAG SCREW". THERE WAS A SURGERY DELAY OF 90 MINUTES AND THERE WERE NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190104 ZNN TRAUMA IMPLANT UNKNOWN ZNN TRAUMA IMPLANT HRS ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other