BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION INSTR.W/BALL-SHAPED TRIGON STR

    MDR report key: 6358879 · Received February 24, 2017

    Report

    Report Number
    9610612-2017-00059
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    January 25, 2017
    Report Date
    April 12, 2017
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: GERMANY. IT WAS REPORTED THAT THE INSTRUMENT JAMMED WITH THE CEMENTED IMPLANT. THE REMOVAL OF THE INSTRUMENT WAS ONLY POSSIBLE BY REMOVING THE IMPLANT. THERE WAS NO CEMENT FOUND IN THE IMPLANT. THE BIOLOX CERAMIC HEAD COULD NO LONGER BE DETACHED FROM THE CONE. CONCOMITANT MEDICAL PRODUCTS: ND844R / NSERTION INSTR.W/BALL-SHAPED TRIGON STR; NU272K / EXCIA T CEMENTED 12/14 SIZE 12MM; NK562D / BIOLOX DELTA PROSTH. HEAD 12/14 32MML.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: ALL COMPONENTS WERE INVESTIGATED VISUALLY. THE ND844R INSERTION INSTR.W/BALL-SHAPED TRIGON STR (OLD VERSION)WAS TESTED AND CHECKED. THE WORKING END SHOWS NO NOTICEABLE OR UNUSUAL DAMAGE. TO NOTE: THE WORKING END OF THE ND844R HAS BEEN CHANGED. CHANGING NUMBER: (B)(4) REGARDING FOR THE SMOOTH EXTRACTION OF THE STEM WITH NO BONE CEMENT RESIDUES A TEST, TOGETHER WITH THE DEVELOPMENT AND THE MARKETING DEPARTMENT WAS PERFORMED IN OUR BIOMECHANICS LABORATORY. IN THIS TEST A BONE CEMENTATION WITH AN EXCIA T CEMENTED 12/14 SIZE 12MM WITH UNCOOLED PALACOS BONE CEMENT AND VACUUM MIXING TECHNOLOGY ON AN ARTIFICIAL BONE WAS RECONSTRUCTED. RESULT: THE STEM IS FIXED STRONG IN THE ARTIFICIAL BONE. AN EXTRACTION WAS NOT POSSIBLE. 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 PROBABLY USER RELATED. WE ASSUME THAT THE ND844R INSERTION INSTR.W/BALL-SHAPED TRIGON STR WAS APPLIED IN AN UNUSUAL ANGLE, THIS LED PROBABLE TO A STICKING. AS A RESULT OF THIS THE FIRST IMPLANTED STEM CHANGED ITS POSITION. WE ALSO EXPECTING THAT THE BONE CEMENT WAS NOT USED IN A CORRECT WAY. PROBABLY THE WAITING PERIOD FOR THE HARDENING OF THE CEMENT WAS NOT KEPT CORRECTLY, SO THE STEM HAS COME OFF. RATIONAL: WE EXCLUDE A PRODUCT OR DESIGN FAILURE BECAUSE NO MORE COMPLAINTS WITH THE SAME BATCH ARE REGISTERED IN OUR SYSTEM. CORRECTIVE ACTION: ACCORDING TO SOP SA-DE13-M-4-2-01-010 A CAPA IS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140019 INSERTION INSTR.W/BALL-SHAPED TRIGON STR HIP ENDOPROSTHETICS LXH AESCULAP IMPLANT SYSTEMS ND844R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ND844R / INSERTION INSTR.W/BALL-SHAPED TRIGON STR| NK562D / BIOLOX DELTA PROSTH. HEAD 12/14 32MML| NU272K / EXCIA T CEMENTED 12/14 SIZE 12MM| ND844R / INSERTION INSTR.W/BALL-SHAPED TRIGON STR| NK562D / BIOLOX DELTA PROSTH. HEAD 12/14 32MML| NU272K / EXCIA T CEMENTED 12/14 SIZE 12MM