BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURO MENISCAL COMPONENT F2 10MM

    MDR report key: 8828208 · Received July 25, 2019

    Report

    Report Number
    9610612-2019-00476
    Event Type
    Injury
    Date Received
    July 25, 2019
    Report Date
    July 25, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    KRO
    PMA / PMN Number
    K120955
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DATA: (B)(6). MANUFACTURING EVALUATION: THE RECEIVED DEVICES WERE DELIVERED IN A CONTAMINATED STATUS, THEREFORE, THE COMPONENTS WERE DECONTAMINATED INTERNALLY ACCORDING TO INTERNAL STANDARDS. THE ROTATION AXIS (NR872201) HAS FRACTURED BELOW THE TAPER. X-RAYS WERE RECEIVED; THEY DID NOT PROVIDE ANY HINTS FOR THE CAUSE OF THE FRACTURE. INVESTIGATION: THE TAPER OF THE ROTATION AXIS SHOWS VISIBLE DAMAGE ON THE SURFACE. THE ROTATION AXIS (NB 014206) LOCKNUT IS NO LONGER LOCATED/FIXED ON THE THREAD OF THE ROTATION AXIS. THE BREAKAGE SURFACE OF THE LARGER DISTAL PART OF THE ROTATION AXIS SHOWS MAINLY SECONDARY DAMAGES. THE PROXIMAL FRAGMENT SHOWED SO-CALLED ARREST LINES WHICH ARE TYPICAL FOR A DYNAMIC FATIGUE FRACTURE. IN ADDITION TO THIS, THERE ARE ALSO AREAS OF SECONDARY DAMAGES VISIBLE (SHINY SURFACE). BOTH FRACTURE SURFACES EXHIBIT NO MATERIAL DEFECTS LIKE FOREIGN PARTICLES, INCLUSIONS, OR BLOW HOLES. THE THREAD OF THE ROTATION AXIS NR872201 AS WELL AS THE THREAD OF THE ROTATION AXIS LOCKNUT NB014206 SHOW NO SERIOUS VISIBLE DAMAGES. THE MENISCAL COMPONENT (NR880200) SHOW NO SERIOUS DAMAGES. THE WEAR MARKS ARE LOW IN RELATION TO THE IN-VIVO TIME. THERE ARE LITTLE METAL INCLUSIONS ON THE GLIDING SURFACE. THE LOCKING RING (NR872202) AND THE BEARING FOR ROTATION AXIS (NR872203) SHOW NO UNUSUAL DAMAGES. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS AND FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THESE BATCHES. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS LIKELY PATIENT/USAGE RELATED. RATIONALE: ACCORDING TO THE QUALITY STANDARD AND DEVICE HISTORY RECORD (DHR) FILES A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. FURTHERMORE, THERE ARE NO HINTS OF A MATERIAL OR MANUFACTURING PROBLEM. THE FRACTURE SURFACE EXHIBITS NO MATERIAL DEFECTS LIKE FOREIGN PARTICLES, INCLUSIONS OR BLOW HOLES. IT APPEARS THAT THE FRACTURE HAS OCCURRED DUE TO A PATIENT RELATED OVERLOAD SITUATION; THE PATIENT WEIGHT WAS NOTED AS 93 KG. FURTHERMORE, IT SHOULD BE MENTIONED THAT THE VISIBLE DAMAGES ON THE TAPER OF THE ROTATION AXIS COULD BE AN INDICATION THAT THE HINGE CONNECTION OF THE FEMUR HAS BEEN MOVING ON THE TAPER. A REASON COULD BE THAT THE FEMUR SAFETY NUT HAS COME LOOSE, RESPECTIVELY, WAS NOT FIRMLY FITTED. NO CAPA NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE ENDURO MENISCAL COMPONENT. THE PATIENT WAS IMPLANTED WITH AN ENDURO KNEE IMPLANT SYSTEM ON (B)(6) 2012. IT WAS NOTED THAT THERE HAD BEEN INCREASING INSTABILITY SINCE THE BEGINNING OF (B)(6) 2019. RADIOLOGICAL RESULTS SHOWED A CLEAR CONE FRACTURE. THERE WAS A REVISION ON (B)(6) 2019 DUE TO THE BROKEN AXIS OF THE MENISCAL F2 IMPLANT. ADDITIONAL DETAILS ABOUT OPERATIVE COURSE AND PATIENT OUTCOME WERE NOT PROVIDED. CONCOMITANT COMPONENTS: TIBIA CEMENTED T2, FEMUR CEMENTED, FEMUR EXTENSION STEM AND NUT, 12 MM TIBIAL WEDGES, TIBIAL OFFSET STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620834 ENDURO MENISCAL COMPONENT F2 10MM KNEE ENDOPROSTHETICS KRO AESCULAP AG NR880M 51858682

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R