BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IC-BIPOLAR HEAD COCRMO

    MDR report key: 12347477 · Received August 20, 2021

    Report

    Report Number
    3012523063-2021-00003
    Event Type
    Injury
    Date Received
    August 20, 2021
    Date of Event
    August 4, 2021
    Report Date
    August 20, 2021
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    KWY
    PMA / PMN Number
    K181778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REMARK IMPLANTCAST GMBH: PLEASE BE AWARE OF THE DIFFERENCE BETWEEN THE TERMS DISLOCATION AND DISCONNECTION THAT WERE USED BY IMPLANTCAST GMBH IN THIS REPORT. DISLOCATION: DUE TO THE DESIGN OF THE BI-POLAR HEAD IT IS POSSIBLE THAT THE WHOLE SYSTEM (THE BI-POLAR 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 IC-BIPOLAR HEAD AND THE FEMORAL HEAD. SINCE NEITHER THE PRODUCT ITSELF NOR PICTURES OF IT WERE AVAILABLE NO OPTICAL EVALUATION COULD BE PERFORMED. HOWEVER, THE MANUFACTURING PROTOCOLS AS WELL AS THE INFORMATION MATERIAL DID NOT SHOW ANY SIGNS OF FAILURE OR INCOMPLETENESS, BUT THE INSTRUCTIONS FOR USE LISTS A DISLOCATION AS POSSIBLE ADVERSE EVENT. FOR THE EVALUATION OF THE X-RAY IMAGES, IMPLANTCAST GMBH CONTACTED A PHYSICIAN, WHO IS EXPERIENCED WITH THIS SYSTEM. ACCORDING TO HIM THERE IS AN IMPLANTATION ERROR THAT MAY HAVE CAUSED THE DISLOCATION OF THE IC-BIPOLAR HEAD. THE USED COMBINATION DOES NOT INDUCE ENOUGH JOINT TENSION WHICH INCREASES THE RISK OF A DISLOCATION. HOWEVER, IT IS ALSO WORTH NOTING THAT THERE IS A NOTICEABLE CLUSTERING OF INCIDENTS FROM (B)(6), AS ALL INCIDENTS REPORTED IN RECENT TIME HAVE HAPPENED THERE. LEADING TO THE ASSUMPTION THAT THERE ALSO MIGHT BE A KOREAN RELATED PROBLEM INVOLVED. WITH REGARD TO THEIR CULTURE IT IS WORTH MENTIONING, THAT A MAIN WAY OF SITTING IS IN A TAILOR SEAT, WHICH NEEDS A BIG RANGE OF MOTION OF THE HIP JOINT. IF AN ATTEMPT IS MADE TO REACH THIS RANGE OF MOTION TOO EARLY AFTER IMPLANTATION ALONG WITH A DECREASED JOINT TENSION DUE TO IMPLANTATION ERROR, DISLOCATION MAY OCCUR AS WELL. WITH ONLY 2 WEEKS THE IMPLANTATION TIME IS RATHER SMALL. THEREFORE, REGARDING THE CASE AT HAND IT IS POSSIBLE, THAT THE RANGE OF MOTION THAT WAS REACHED WAS TOO BIG FOR THIS IMPLANTATION STADIUM. THIS ASSUMPTION IS ALSO TRANSFERABLE TO MOST OF THE OTHER KNOWN CASES WITH THIS ERROR PATTERN. AS TO THE DISCONNECTION, SINCE IT IS KNOWN THAT IN THIS CASE FIRST A DISLOCATION AND AFTERWARDS A DISCONNECTION TOOK PLACE IT IS LEGITIMATE, TO ASSUME THAT THE DISCONNECTION OCCURRED DUE TO A (PRESUMABLE CLOSED) REPOSITION THAT FAILED. SO, ALL IN ALL IT IS SAFE TO ASSUME THAT AT FIRST THE SYSTEM DISLOCATED AND AFTERWARDS IT GOT DISCONNECTED DUE TO A FAILED REPOSITIONING. FURTHERMORE, IT IS ASSUMED THAT THE DISLOCATION OCCURS DUE TO IMPLANTATION ERROR AND / OR DUE TO (B)(6) SPECIFIC PROBLEMS.

    Description of Event or Problem · 1

    ON (B)(6) 2021 IMPLANTCAST GMBH RECEIVED THE MESSAGE THAT AN IC-BIPOLAR HEAD DISLOCATED AND DISCONNECTED AFTER ABOUT 2 WEEKS OF IMPLANTATION TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247890 IC-BIPOLAR HEAD COCRMO IC-BIPOLAR HEAD COCRMO Ø 28/51MM KWY IMPLANTCAST GMBH 21510051

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R