BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IC-BIPOLAR HEAD COCRMO Ø 28 / 48 MM

    MDR report key: 21975024 · Received May 7, 2025

    Report

    Report Number
    3012523063-2025-00044
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    March 31, 2025
    Report Date
    May 7, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    KWY
    PMA / PMN Number
    K191569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO THE IMPLANTCAST GMBH THAT AN IC-BIPOLAR HEAD COCRMO Ø 28 / 48 MM DISLOCATED FROM THE NATURAL ACETABULUM. DURING AN ATTEMPT TO REPOSITION IT IN A CLOSED REDUCTION, THE IC-BIPOLAR HEAD THAN DISCONNECTED FROM THE FEMORAL HEAD. OPTICAL EXAMINATION OF THE EXPLANT WAS NOT POSSIBLE, AS IT WAS NOT PROVIDED TO THE IMPLANTCAST GMBH. THE MANUFACTURING DOCUMENTS AND DESCRIPTION OF THE SURGICAL TECHNIQUE WERE CHECKED, NO DEVIATIONS WERE FOUND. IT IS POSSIBLE THAT THE DISLOCATION WAS CAUSED BY TOO LITTLE LIGAMENT TENSION, WHICH ALLOWED THE IC-BIPOLAR HEAD TO SLIP OUT OF THE JOINT CAPSULE. HOWEVER, NO INFORMATION IS AVAILABLE TO SUPPORT THIS HYPOTHESIS. IN CASE A CLOSED REDUCTION IS PERFORMED AFTER DISLOCATION OF THE IC-BIPOLAR HEAD COCRMO FROM THE NATURAL ACETABULUM, THERE IS A RISK OF SEPARATION OF THE IC-HEAD FROM THE IC-BIPOLAR HEAD COCRMO. ALL IN ALL NO DEFINITIVE CONCLUSION CAN BE DRAWN AS TO WHY THE IC-BIPOLAR HEAD DISLOCATED. HOWEVER, IT IS ASSUMED THAT THE DISCONNECTION IS DUE TO THE CLOSED REDUCTION THAT WAS PERFORMED AFTERWARDS. THE EVENT WAS ASSIGNED TO THE HAZARD I "DISLOCATION / INSTABILITY" AND THE HAZARD II "SEPARATION /DISCONNECTION OF THE FEMORAL HEAD OUT OF BIPOLAR HEAD" IN THE ASSOCIATED RISK MANAGEMENT OVERVIEW.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "DURING THE CLOSED REDUCTION OF THE BIPOLAR HEAD UNDER ANAESTHESIA, THE STEEL HEAD DISCONNECTED FROM THE BIPOLAR HEAD WITHOUT THE SNAP RING COMING LOOSE." REMARK IC-GMBH: THE TERMS DISCONNECTION AND DISLOCATION ARE USED AS FOLLOWS DISLOCATION: DUE TO THE DESIGN OF THE BIPOLAR HEAD IT IS POSSIBLE THAT THE WHOLE SYSTEM (THE BIPOLAR HEAD AND THE FEMORAL HEAD) CAN DISLOCATE OUT OF THE NATURAL ACETABULUM AS A WHOLE. DISCONNECTION: IT IS ALSO POSSIBLE THAT THE INDIVIDUAL COMPONENTS OF THIS SYSTEM DISCONNECT, RESULTING IN A SEPARATION OF THE BIPOLAR HEAD AND THE FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1872812 IC-BIPOLAR HEAD COCRMO Ø 28 / 48 MM FEMORAL HEAD KWY IMPLANTCAST GMBH 21510048

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention