BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS® UNI IM ADAPTER

    MDR report key: 22529067 · Received July 17, 2025

    Report

    Report Number
    3012523063-2025-00072
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 17, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, AN ACS® UNI IM ADAPTER COULD NOT BE CONNECTED ONTO AN ACS® UNI FEMORAL RESECTION GUIDE. BOTH PRODUCTS WERE PROVIDED FOR AN OPTICAL EXAMINATION. THE FEMORAL RESECTION GUIDE PRESENTS NO CONSPICUOUS FEATURES. THE UNI IM ADAPTER PRESENTS SOME MINOR DAMAGES IN THE FORM OF CIRCUMFERENT SCRATCHES AROUND THE PIN PART FOR CONNECTION TO THE RESECTION GUIDE. IT IS KNOWN THAT THE ISSUE WITH THE UNI IM ADAPTER DID NOT OCCUR INTRAOPERATIVELY. THE SURGERY WAS ABORTED BEFOREHAND DUE TO OTHER REASONS. THE ISSUE WAS DISCOVERED WHEN THESE PRODUCTS WERE USED DURING A TRAINING. THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF BOTH THE ADAPTER AND THE RESECTION GUIDE WERE CHECKED. THESE DID NOT REVEAL ANY ERRORS. THE SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE CHECKED AND SHOWED NO DEVIATIONS. THE INCOMPATIBILITY BETWEEN BOTH PARTS COULD BE RECREATED DURING THE INVESTIGATION. ALSO, DURING THE INVESTIGATION ANOTHER ADAPTER WAS USED TO CONNECT IT ONTO THE RESECTION GUIDE. THIS WAS POSSIBLE WITHOUT ANY ISSUES. THEREFORE, IT IS ASSUMED THAT THE INCOMPATIBILITY OCCURRED SOLELY DUE TO THE ADAPTER. BASED ON THE AVAILABLE INFORMATION, NO FAILURE OF THE DESIGN OR DURING THE MANUFACTURING OF THE ADAPTER COULD BE DETERMINED. IT IS ASSUMED THAT THE INCOMPATIBILITY ISSUE OCCURRED DUE TO THE SCRATCHES PRESENT ON THE CONNECTION PIN. HOWEVER, IT CANNOT BE DETERMINED WITHOUT A DOUBT HOW EXACTLY THESE SCRATCHES WERE CREATED. THE PRODUCT WAS MANUFACTURED IN MARCH 2025 AND IS THEREFORE IN USE FOR JUST 3 MONTHS. A POTENTIAL CAUSE COULD BE AN UNINTENTIONAL USER ERROR (IF E.G. THE ADAPTER WAS CONNECTED TO THE RESECTION GUIDE TILTED), BUT THIS NEITHER BE CONFIRMED NOR DENIED DUE TO A LACK OF INFORMATION. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERNS "ATTACHMENT DOES NOT FIT INSTRUMENT/IMPLANT" AND "CHANGE OF SURFACE" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANT CAST GMBH: "DURING THE EXAMINATION OF THE INSTRUMENTS, IT WAS FOUND THAT THE ACS UNI IM ADAPTER DOES NOT FIT INTO THE TWO HOLES OF THE ACS UNNI FEMORAL RESECTION GUIDE. THERE WERE NO IMPACTS, AS THE SURGERY DID NOT TAKE PLACE!" NOTE: BASED ON THE PROVIDED INFORMATION, THE ISSUE DID NOT OCCUR INTRAOPERATIVELY, AS THE SURGERY WAS ABORTED DUE TO OTHER REASONS. THE ISSUE WAS THEN DISCOVERED DURING A TRAINING WHICH WAS DONE WITH THE AFFECTED PRODUCTS. HOWEVER, IF THE SURGERY HAS NOT BEEN ABORTED BEFOREHAND, IT WAS POSSIBLE THAT THE EVENT TOOK PLACE INTRAOPERATIVELY INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664720 ACS® UNI IM ADAPTER ADAPTER LXH IMPLANTCAST GMBH 42161709

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other ACS® UNI FEMORAL RESECTION GUIDE ANATOMIC SZ. 2