BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS® FEMORAL TRIAL COMPONENT SIZE 7 RIGHT

    MDR report key: 23604391 · Received November 20, 2025

    Report

    Report Number
    3012523063-2025-00094
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    October 23, 2025
    Report Date
    March 6, 2026
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    HWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT AN ACS® FEMORAL TRIAL COMPONENT WAS INCORRECTLY ENGRAVED WITH THE SIDE "RIGHT" ALTHOUGH IT WAS LEFT COMPONENT. THE PRODUCT IN QUESTION WAS PROVIDED FOR AN OPTICAL EXAMINATION AND THE ERROR PATTERN COULD BE CONFIRMED. ALL ACS® FEMORAL TRIAL COMPONENTS SIZE 7 (LEFT AND RIGHT SIDE) WERE CHECKED WHICH WERE IN STOCK AT IMPLANTCAST WITH SPECIAL FOCUS ON THE LOT NUMBERS 15310HD0 (AFFECTED LOT NUMBER WAS 15310HD035). NO INCORRECT LEFT COMPONENTS WERE FOUND. HOWEVER, 4 MORE INCORRECT RIGHT COMPONENTS COULD BE FOUND: LOT 15310HD033, 15310HD037, 15310HD038 AND 15310HD039. ALL OTHER PRODUCTS FROM THIS CHARGE WERE CORRECTLY MANUFACTURED. THE WHOLE CHARGE INCLUDES THE LOT NUMBERS FROM 15310HD001 TILL 15310HD040. THESE PRODUCTS ARE SEPARATED INTO 5 WORK ORDERS EACH INCLUDING 8 PRODUCTS AS FOLLOWS: WORK ORDER 1: LOT 15310HD001 TILL 008, WORK ORDER 2: LOT 15310HD009 TILL 016, WORK ORDER 3: LOT 15310HD017 TILL 024, WORK ORDER 4: LOT 15310HD025 TILL 032, WORK ORDER 5: LOT 15310HD033 TILL 040. DURING THE INVESTIGATION, IT WAS NOTED THAT ONLY PRODUCTS FROM WORK ORDER 5 WERE FOUND TO BE INCORRECT, ALL OTHER PRODUCTS FROM THIS CHARGE WERE CORRECT. THE MISSING LOT NUMBERS 034, 036 AND 040 WERE ALREADY SCRAPPED DURING THE MANUFACTURING PROCESS. THEREFORE, ALL PRODUCTS FROM THIS FAULTY WORK ORDER WERE SECURED. THE AFFECTED PRODUCT FROM THIS INCIDENT (035) WILL BE ARCHIVED AND THE REMAINING 4 PRODUCTS (033, 037, 038 AND 039) WERE SCRAPPED, HENCE NO FAULTY PRODUCT WILL REMAIN ON THE MARKET OR POSE ANY THREAT TO A PATIENT. IT CAN FURTHER BE NOTED HERE THAT NO INCORRECT PRODUCT FROM THIS CHARGE WAS EVER ON THE US MARKET. BASED ON THE INVESTIGATION IT IS SAFE TO SAY THAT THE ERROR OCCURRED DURING THE MANUFACTURING PROCESS OF THE FAULTY PRODUCTS AND WAS NOT NOTICED AT ANY POINT DURING THE MANUFACTURING. HOWEVER, WHEN EXACTLY THIS HAPPENED CANNOT BE DETERMINED WITHOUT A DOUBT. THE EVENT WAS ASSIGNED TO THE ERROR PATTERN "PRODUCTION ERROR" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT AN ACS® FEMORAL TRIAL COMPONENT WAS INCORRECTLY ENGRAVED WITH THE SIDE "RIGHT" ALTHOUGH IT WAS LEFT COMPONENT. THE PRODUCT IN QUESTION WAS PROVIDED FOR AN OPTICAL EXAMINATION AND THE ERROR PATTERN COULD BE CONFIRMED. ALL ACS® FEMORAL TRIAL COMPONENTS SIZE 7 (LEFT AND RIGHT SIDE) WERE CHECKED WHICH WERE IN STOCK AT IMPLANTCAST WITH SPECIAL FOCUS ON THE LOT NUMBERS 15310HD0* (AFFECTED LOT NUMBER WAS 15310HD035). NO INCORRECT LEFT COMPONENTS WERE FOUND. HOWEVER, 4 MORE INCORRECT RIGHT COMPONENTS COULD BE FOUND: LOT 15310HD033, 15310HD037, 15310HD038 AND 15310HD039. ALL OTHER PRODUCTS FROM THIS CHARGE WERE CORRECTLY MANUFACTURED. THE WHOLE CHARGE INCLUDES THE LOT NUMBERS FROM 15310HD001 TILL 15310HD040. THESE PRODUCTS ARE SEPARATED INTO 5 WORK ORDERS AS FOLLOWS: WORK ORDER 1: LOT 15310HD001 TILL 008, WORK ORDER 2: LOT 15310HD009 TILL 016, WORK ORDER 3: LOT 15310HD017 TILL 024, WORK ORDER 4: LOT 15310HD025 TILL 032, WORK ORDER 5: LOT 15310HD033 TILL 040. DURING THE INVESTIGATION, IT WAS NOTED THAT ONLY PRODUCTS FROM WORK ORDER 5 WERE FOUND TO BE INCORRECT, ALL OTHER PRODUCTS FROM THIS CHARGE WERE CORRECT. THE MISSING LOT NUMBERS *034, 036 AND 040 WERE ALREADY SCRAPPED DURING THE MANUFACTURING PROCESS. THEREFORE, ALL PRODUCTS FROM THIS FAULTY WORK ORDER WERE SECURED. THE AFFECTED PRODUCT FROM THIS INCIDENT (035) WILL BE ARCHIVED AND THE REMAINING 4 PRODUCTS (033, 037, 038 AND (039) WILL BE SCRAPPED, HENCE NO FAULTY PRODUCT WILL REMAIN ON THE MARKET OR POSE ANY THREAT TO A PATIENT. IT CAN FURTHER BE NOTED HERE THAT NO INCORRECT PRODUCT FROM THIS CHARGE WAS EVER ON THE US MARKET. THE ROOT CAUSE ANALYSIS IS NOT FINISHED YET. THEREFORE, IT CANNOT BE SAID WITHOUT A DOUBT WHERE EXACTLY THE ERROR ORIGINATED. HOWEVER, IT IS SAFE TO SAY THAT THERE WAS AN ERROR DURING THE MANUFACTURING PROCESS, WHICH WAS NOT NOTICED AT ANY POINT. THE EVENT WAS ASSIGNED TO THE ERROR PATTERN "PRODUCTION ERROR" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "[...] THE FEMUR TRIAL COMPONENT LABELLED 7R IS FOR THE LEFT SIDE, AS IS ITS CORRECTLY LABELLED NEIGHBOUR. [...]" "INCORRECT LABELLING ON THE PRODUCT. THE SIDE DESIGNATION 7R ON THE IMPLANT WAS INCORRECT (LEFT/RIGHT). BOTH SAMPLE IMPLANTS SHOWN IN THE PICTURE SHOULD HAVE BEEN LABELLED 7L. AN IMPLANT FOR THE RIGHT SIDE WAS MISSING FROM THE INSTRUMENT CONTAINER." NOTE: IT IS KNOWN THAT THE EVENT OCCURRED INTRAOPERATIVELY AND THAT IT CAUSED A PROLONGATION OF THE SURGERY OF 60 MINUTES. THE IMPLANTATION WAS DONE VIA MANUAL WORK AND EXPERIENCE BY THE ATTENDING SURGEON WITHOUT TRIAL.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "THE FEMUR TRIAL COMPONENT LABELLED 7R IS FOR THE LEFT SIDE, AS IS ITS CORRECTLY LABELLED NEIGHBOUR. " "INCORRECT LABELLING ON THE PRODUCT. THE SIDE DESIGNATION 7R ON THE IMPLANT WAS INCORRECT (LEFT/RIGHT). BOTH SAMPLE IMPLANTS SHOWN IN THE PICTURE SHOULD HAVE BEEN LABELLED 7L. AN IMPLANT FOR THE RIGHT SIDE WAS MISSING FROM THE INSTRUMENT CONTAINER." NOTE: IT IS KNOWN THAT THE EVENT OCCURRED INTRAOPERATIVELY AND THAT IT CAUSED A PROLONGATION OF THE SURGERY OF 60 MINUTES. THE IMPLANTATION WAS DONE VIA MANUAL WORK AND EXPERIENCE BY THE ATTENDING SURGEON WITHOUT TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573838 ACS® FEMORAL TRIAL COMPONENT SIZE 7 RIGHT TRIAL COMPONENT HWT IMPLANTCAST GMBH 42103117

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other