BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLACROSS® E PE INSERT 0° 36 / 48 MM

    MDR report key: 22540615 · Received July 18, 2025

    Report

    Report Number
    3012523063-2025-00074
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 18, 2025
    Report Date
    August 29, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    OQI
    PMA / PMN Number
    K180263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN IMPLANTATION AN IMPLACROSS® E PE INSERT 0° 36 / 48 MM COULD NOT BE INSERTED INTO AN ECOFIT® CUP EPORE® NH CEMENTLESS. A DIFFERENT IMPLACROSS® E PE INSERT 0° [?] 36 / 48 MM FROM THE SAME BATCH HOWEVER COULD BE INSERTED WITHOUT PROBLEMS. THE IMPLACROSS® E PE INSERT WAS AVAILABLE FOR AN OPTICAL EXAMINATION. SMALL SCRATCHES AND DAMAGES AROUND THE OUTER EDGE AND ON THE SURFACE WERE VISIBLE AND MOST LIKELY WERE CAUSED BY THE IMPLANTATION ATTEMPT. ADDITIONALLY, THE IMPLACROSS® E PE INSERT WAS EVALUATED BY THE QUALITY ASSURANCE DEPARTMENT AND ALL MEASUREMENTS RELEVANT FOR THE INSERTION INTO THE CUP WERE WITHIN THE SPECIFICATIONS. THE MANUFACTURING DOCUMENTS WERE CHECKED AND DO NOT SHOW ANY DEVIATIONS. NEITHER THE SURGICAL TECHNIQUES NOR THE INSTRUCTIONS FOR USE SHOW ANY DEVIATIONS. AS THE MEASUREMENTS OF THE PE INSERT WERE WITHIN THE SPECIFICATIONS A TECHNICAL CAUSE COULD BE RULED OUT. MOST LIKELY THE PROBLEM OCCURRED DUE TO UNIDEAL HANDLING BY THE SURGEON. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERN "INCOMPATIBILITY" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    DURING AN IMPLANTATION AN IMPLACROSS® E PE INSERT 0° 36 / 48 MM COULD NOT BE INSERTED INTO AN ECOFIT® CUP EPORE® NH CEMENTLESS. A DIFFERENT IMPLACROSS® E PE INSERT 0° 36 / 48 MM FROM THE SAME BATCH HOWEVER COULD BE INSERTED WITHOUT PROBLEMS. NEITHER THE EXPLANTS NOR INTRAOPERATIVE IMAGES ARE AVAILABLE, THEREFORE NO OPTICAL EXAMINATION CAN BE EXECUTED. THE MANUFACTURING DOCUMENTS WERE CHECKED AND DO NOT SHOW ANY DEVIATIONS. NEITHER THE SURGICAL TECHNIQUES NOR THE INSTRUCTIONS FOR USE SHOW ANY DEVIATIONS. BASED ON THE AVAILABLE DATA, NO TECHNICAL CAUSE COULD BE FOUND. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERN "INCOMPATIBILITY" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "AFTER IMPLANTING THE CUP, THE SURGEON [...] WANTED TO HAMMER IN THE INLAY -> BUT COULD NOT GET IT IN THERE WERE NO PROBLEMS WHEN TRYING ANOTHER INLAY" FOLLOW-UP: IMPLANTCAST GMBH WAS PROVIDED WITH THE AFFECTED PRODUCT ON (B)(6) 2025.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "AFTER IMPLANTING THE CUP, THE SURGEON [...] WANTED TO HAMMER IN THE INLAY -> BUT COULD NOT GET IT IN. THERE WERE NO PROBLEMS WHEN TRYING ANOTHER INLAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196393 IMPLACROSS® E PE INSERT 0° 36 / 48 MM PE INSERT OQI IMPLANTCAST GMBH 02333648

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Required Intervention ECOFIT® CUP EPORE® NH CEMENTLESS Ø 58MM INCL. CENT.| ECOFIT® CUP EPORE® NH CEMENTLESS Ø 58MM INCL. CENT.