BEUDAMED
    FDA Adverse Event Injury Summary report: N

    135 DEG DHS® PLATE-SHORT BARREL 4 HOLES/78MM

    MDR report key: 3983715 · Received August 6, 2014

    Report

    Report Number
    3003506883-2014-10082
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    PK791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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

    IT WAS REPORTED A HARDWARE REMOVAL WAS PERFORMED FOR A DYNAMIC HIP SYSTEM, THERE WAS REPORTED TO BE NO PATIENT REACTION, INFECTION AND OR DAMAGE RELATED TO THE DEVICE. THE SURGEON'S PRIMARY REASON FOR EXPLANT WAS REPORTED TO BE DUE TO THE PATIENT HAVING AVASCULAR NECROSIS (AVN) AND WILL NEED TO BE SCHEDULED FOR A TOTAL HIP IN THE FUTURE. THE OUTCOME OF EXPLANT SURGERY WAS SUCCESSFUL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460405 135 DEG DHS® PLATE-SHORT BARREL 4 HOLES/78MM APPLIANCE,FIXATION,NAIL KTT SYNTHES ELMIRA 5336127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention