BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GAMMA3 LAG SCREW

    MDR report key: 10417733 · Received August 17, 2020

    Report

    Report Number
    0009610622-2020-00473
    Event Type
    Injury
    Date Received
    August 17, 2020
    Date of Event
    May 23, 2016
    Report Date
    August 17, 2020
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. DEVICE DISPOSITION IS UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY (B)(6) UNIVERSITY MEDICAL CENTER, IN (B)(6). THE TITLE OF THIS REPORT IS ¿LATE OCCURRING MEDIAL MIGRATION OF A LAG SCREW IN GAMMA NAILING¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿GAMMA3 NAILING¿ PROSTHESIS SYSTEM. THE ARTICLE CAN BE FOUND AT HTTP://DX.DOI.ORG/10.1155/2016/5201674. WITHIN THAT PUBLICATION WHICH INCLUDED SINGLE PATIENT, POST-OPERATIVE COMPLICATIONS WERE REPORTED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS OR PATIENT INFORMATION FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINTS WERE INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATIONS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES ACUTE PAIN AND INABILITY TO WALK FOR 2 DAYS WITH MEDIAL MIGRATION OF THE LAG SCREW WHICH WAS TREATED BY REMOVAL OF GAMMA NAIL AND REPLACEMENT BY A CEMENTED TOTAL HIP ARTHROPLASTY. THE REPORT STATES: ¿UNFORTUNATELY, THREE MONTHS AFTER THE OPERATION THE PATIENT PRESENTED HERSELF AGAIN IN THE ED WITH ACUTE PAIN IN HER LEFT HIP FOR 2 DAYS AND AN INABILITY TO WALK. THERE WAS NO PRECEDING TRAUMA AND THERE WERE NO SIGNS OF AN INFECTION. THE X-RAY IN THE ED SHOWED MEDIAL MIGRATION OF THE LAG SCREW (FIGURE 5). IT WAS DECIDED TO REMOVE THE GAMMA NAIL AND REPLACE IT BY A CEMENTED TOTAL HIP ARTHROPLASTY (EXETER STEM, RIMFIT CUP, STRYKER) DURING THE SAME SESSION. INTRAOPERATIVELY, THE FRACTURE APPEARED CONSOLIDATED AND THERE WERE NO SIGNS OF INFECTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878453 UNKNOWN GAMMA3 LAG SCREW IMPLANT HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 Required Intervention