BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURO MENISCAL COMPONENT F2 12MM

    MDR report key: 6094494 · Received November 10, 2016

    Report

    Report Number
    3005673311-2016-00191
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Report Date
    April 12, 2018
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    KRO
    PMA / PMN Number
    K101815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH THE KEYENCE VHX-5000 DIGITAL MICROSCOPE AND A PANASONIC DMC TZ8 DIGITAL CAMERA. WE MADE A VISUAL INSPECTION OF THE MENISCAL COMPONENT. HERE WE FOUND VISIBLE DAMAGE. ADDITIONALLY WE FOUND FIXED METAL CHIPS. NEXT WE MADE A VISUAL INSPECTION OF THE BEARING, WHERE WE FOUND VISIBLE DAMAGE AND FIXED METAL CHIPS. VISIBLE DAMAGE AND DISCOLORATION WAS FOUND ON NEARLY EVERY COMPONENT OF THE COMPLAINED PART. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. 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 PROBABLY NOT PRODUCT RELATED. RATIONAL: ACCORDING TO THE QUALITY STANDARD AND DHR FILES, A MATERIAL DEFECT OR PRODUCTION ERROR CAN BE EXCLUDED. NO PORES INCLUSIONS OR FOREIGN BODIES COULD BE FOUND ON THE POINT OF RUPTURE. THE STOP MARKS COULD BE CAUSED BY HYPEREXTENSION. FOR SOME TIME THIS COULD BE INDICATED AS AN ADDITIONAL LOAD SITUATION FOR KNEE PROSTHESIS. NO CAPA IS NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NR881M / ENDURO MENISCAL COMPONENT F2 12MM R00518 / ENDURO FEMORAL COMP. CEMENTED F2 L AS.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINTS: (B)(6). IT WAS REPORTED THAT THE PATIENT FELL 4 MONTHS AGO, AND FRACTURED THEIR FEMUR AND DISLOCATED THEIR IMPLANT ROTATION AXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744826 ENDURO MENISCAL COMPONENT F2 12MM GLIDING SURFACES/PATELLAS ENDURO KRO AESCULAP IMPLANT SYSTEMS NR881M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R