BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVATION F MENISCAL COMP.T3 RM/LM 7MM

    MDR report key: 6109495 · Received November 17, 2016

    Report

    Report Number
    3005673311-2016-00195
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 17, 2016
    Report Date
    September 20, 2017
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    HRY
    PMA / PMN Number
    K081293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DUE TO THE CIRCUMSTANCES THAT WE DID NOT RECEIVE ANY DEVICES, A DETAILED INVESTIGATION IS NOT POSSIBLE. THIS CASE WAS DISCUSSED WITH A SPECIALIST FROM THE MARKETING DEPARTMENT. CONCLUSION AND ROOT CAUSE: A DEFINITIVE CONCLUSION AND ROOT CAUSE COULD NOT BE DETERMINED BECAUSE WE DID NOT RECEIVE ANY DEVICES FOR A DETAILED INVESTIGATION. BASED ON OUR QUALITY STANDARDS WE EXCLUDE A MANUFACTURING ERROR. RATIONAL: ACCORDING TO THE RESPONSIBLE PRODUCT MANAGER, THE MENTIONED MOVEMENT OF THE MENISCAL COMPONENT, RECOGNIZED BY THE USER , IS CAUSED DUE TO A TOLERANCE WITHIN SPECIFICATION. DEPENDING ON THE TOLERANCE THE PLAY IS HIGHER OR LOWER. THIS SITUATION HAS ALREADY BEEN TESTED IN A BIOMECHANIC TEST IN RESPECT TO ABRASION. RESULT: THE ABRASION RESULTS OF THE COMPONENTS WITH PLAY ARE PERMITTED FOR THIS PRODUCT. FURTHERMORE, THE PLAY BETWEEN COMPONENTS WILL DECREASE BECAUSE THE BODY TEMPERATURE (37°C) LEAD TO AN EXTENSION OF THE METAL AND PE COMPONENT. UNLIKELY BUT POSSIBLE IN GENERAL, THE ROOT CAUSE OF THIS FAILURE COULD BE THAT CEMENT RESIDUES OR SOFT TISSUES AT THE JOINING POINT, PREVENTED A PROPER FIT OF THE COMPONENT. NO CAPA IS NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT DURING A KNEE SURGERY, THE INLAY WOULD NOT FIT PROPERLY. THERE WAS AN AUDIBLE SNAP SOUND; HOWEVER MICROSCOPIC MOVEMENT OF THE INLAY WAS STILL VISIBLE. CHANGING FROM A 7MM TO AN 8MM DID NOT BRING ANY IMPROVEMENT. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NO187K / UNIVATION XF FEMUR CEMENTED F3 LM. NO164K / UNIVATION XF TIBIA CEMENTED T3 LM. NL472 / UNIVATION F MENISCAL COMP. T3 RM/LM 7MM (2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761781 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM KNEE ENDOPROSTHETICS HRY AESCULAP IMPLANT SYSTEMS NL472

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NL472 / UNIVATION F MENISCAL COMP. T3 RM/LM 7MM| NO164K / UNIVATION XF TIBIA CEMENTED T3 LM| NO187K / UNIVATION XF FEMUR CEMENTED F3 LM