BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTINIA® HIP STEM CEMENTLESS STANDARD SZ. 12

    MDR report key: 21750810 · Received April 2, 2025

    Report

    Report Number
    3012523063-2025-00032
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    February 16, 2025
    Report Date
    April 2, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    LZO
    PMA / PMN Number
    K232371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A 71-YEAR-OLD FEMALE PATIENT HAD TO BE REVISED, SINCE THE IMPLANTED ACTINIA® HIP STEM HAD FRACTURED AFTER AN IMPLANTATION TIME OF APPROX. 3,5 YEARS. A SEVERE PAIN IN THE HIP WAS FELT AFTER THE INCIDENT. NEITHER THE AFFECTED PRODUCTS WERE NOT SENT TO IMPLANTCAST GMBH FOR THE OPTICAL EXAMINATION NOR WERE INTRAOPERATIVELY TAKEN IMAGES FROM THE REVISION SURGERY PROVIDED. THEREFORE, NO OPTICAL EXAMINATION CAN BE PERFORMED. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE ACTINIA® HIP STEM WERE CHECKED. THESE DID NOT REVEAL ANY ERRORS. THE SURGICAL TECHNIQUE AND INSTRUCTIONS FOR USE WERE ALSO CHECKED AND SHOWED NO DEVIATIONS. IN THE INSTRUCTIONS FOR USE IT IS STATED THAT THE LIFESPAN OF AN ORTHOPEDIC JOINT REPLACEMENT CAN BE AFFECTED BY BIOLOGICAL, MATERIAL, AND BIOMECHANICAL FACTORS. CAREFUL PATIENT SELECTION IS CRUCIAL, PARTICULARLY FOR THOSE WHO ARE OVERWEIGHT, HIGHLY ACTIVE, OR UNDER 60 YEARS OLD. IT IS KNOWN THAT THE PATIENT SUFFERS FROM OBESITY GRADE II. ALL IN ALL, NO TECHNICAL ROOT CAUSE COULD BE DETERMINED FOR THE FRACTURE OF THE HIP STEM. A POSSIBLE REASON FOR THE FRACTURE COULD BE THE HIGH BODY WEIGHT OF THE PATIENT CONTRIBUTING TO HIGH STRESSES OF THE IMPLANT DURING THE IMPLANTATION PERIOD OF OVER 3,5 YEARS. IT IS ASSUMED THAT THE PAIN IS EITHER A CONSEQUENCE BY THE FRACTURED HIP STEM OR A CONSEQUENCE DUE TO THE FALL. THEREFORE, THE FALL IS NOT CAUSATIVE FOR THE FRACTURE.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "AT HOME, THE PATIENT COLLAPSED AND FELL AFTER MOVING A TABLE AND FELT SEVERE PAIN IN HER RIGHT HIP " ADDITIONALLY, IMPLANTCAST GMBH RECEIVED THE FOLLOWING USER NOTIFICATION: "AT HOME, AFTER PUSHING A TABLE FORWARD, THE PATIENT COLLAPSED AND FELL, AFTERWARDS SHE FELT SEVERE PAIN IN HER RIGHT HIP" FURTHER INFORMATION WERE PROVIDED FROM THE ATTENDING SURGEON THAT THE ACTINIA HIP STEM WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302619 ACTINIA® HIP STEM CEMENTLESS STANDARD SZ. 12 HIP STEM CEMENTLESS LZO IMPLANTCAST GMBH 80040012

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention ECOFIT® NH CUP CEMENTLESS Ø 50MM REF 02200150| IC-HEAD TITANIUM TAPER 12/14MM Ø 32MM REF 27873215| IMPLACROSS® PE INSERT 10° Ø 32/44MM REF 02243244