BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURO MENISCAL COMPONENT F1 10MM

    MDR report key: 6019056 · Received October 11, 2016

    Report

    Report Number
    3005673311-2016-00178
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    August 8, 2016
    Report Date
    April 10, 2017
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    KRO
    PMA / PMN Number
    K101815
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K): K120955.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE MENISCUS COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH A KEYENCE VHX-5000 DIGITAL MICROSCOPE. THE AXIS HAS FRACTURED ABOVE THE TAPER. THE FRACTURE SURFACE EXHIBITS AN ALTERNATING BENDING FATIGUE FRACTURE. THE INTERNAL TAPER EXHIBITS INDENTATIONS WHICH INDICATE THAT THERE WAS A MOVEMENT PRIOR THE FRACTURE. FURTHERMORE THE INTERNAL THREAD OF THE FEMUR SAFETY NUT AS WELL AS THE EXTERNAL THREAD OF THE FRACTURED ENDURO AXIS SHOWS VISIBLE DAMAGES. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION 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 MOST PROBABLE USER RELATED. WHEN THE CONNECTION BETWEEN THE AXIS TAPER AND THE FEMUR COULD NOT HAVE BEEN FIRMLY FITTED, IF THER WAS A GAP THERE COULD HAVE BEEN MOVEMENT BETWEEN THE COMPONENTS. THIS LEADS TO THE FEMUR SAFETY NUT UNSCREWING OR TO THE AXIS BREAKING ABOVE THE TAPER. THE LOAD TRANSFER IN THIS CASE IS TRANSMITTED THROUGH NARROWEST PART OF THE AXIS AND NOT THROUGH THE MAIN AXIS . THE CAUSE FOR THIS FAILURE TYPE IS USER RELATED. THE TAPER MUST BE FIRMLY PRESSED TOGETHER AND THE FEMUR SAFETY NUT ASSEMBLED AND PRE-TIGHTENED USING THE INSTRUMENT NP420R. THEN THE COUNTER-HOLDER (NP419R) TOGETHER WITH THE INSTRUMENT NP420R IS USED TO TIGHTEN THE TAPER WITH 20NM USING THE TORQUE WRENCH NE184RM THE FEMUR SAFETY NUT IS THEN SCREWED ON USING HOLDER NP455R BY HAND. THE COUNTER HOLDER IS THE ATTACHED TO THE FEMUR AND THE FEMUR SAFETY NUT IS THEN TIGHTENED WITH 20NM USING THE TORQUE WRENCH. WHEN THESE STEPS ARE CARRIED-OUT ACCURATELY IT SHOULD NOT BE POSSIBLE FOR THE CONSTRUCT TO COME APART IN SITU. CORRECTIVE ACTION: ACCORDING TO SOP (B)(4) A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A REVISION SURGERY IN (B)(6) 2015 (INITIAL MED WATCH REPORT SUBMITTED FOR THE FIRST REVISION IS 3005673311-2015-00167). APPROXIMATELY 1 YEAR, 2 MONTHS POST OP, THE PATIENT AWOKE WITH PAIN. PATIENT UNDERWENT REVISION SURGERY IN (B)(6) 2016 FOR BREAKAGE OF THE ROTATION AXIS. ADDITIONAL COMPONENTS INVOLVED: (B)(4) / HINGE RING F1/F2 / LOT 51775381. (B)(4) / HINGE AXIS / LOT 51775381. (B)(4) / ENDURO LOCKING NUT F/ROTATION AXIS / LOT N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668115 ENDURO MENISCAL COMPONENT F1 10MM KNEE ENDOPROSTHESES KRO AESCULAP IMPLANT SYSTEMS NR870M 52116396

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other