BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURO MENISCAL COMPONENT F3 10MM

    MDR report key: 12275107 · Received August 4, 2021

    Report

    Report Number
    9610612-2021-00538
    Event Type
    Injury
    Date Received
    August 4, 2021
    Report Date
    November 11, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    KRO
    PMA / PMN Number
    K101815
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: LEADING DEVICE CHANGED AND ARTICLE CODE CHANGED. ADDED INVOLVED MATERIALS SEE B5. CORRECTED INFORMATION - D4 (PART #, LOT #, UDI). ADDITIONAL INFORMATION - B5, E1 (PHYSICIAN, PHONE), E3, G4 (PMA/510(K) #). MANUFACTURING SITE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THE REPORTED LOT NUMBER; THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION AT THE TIME OF PRODUCTION. ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. NO SIMILAR COMPLAINTS WERE IDENTIFIED AGAINST THE SAME LOT NUMBER WITH A SIMILAR REPORTED EVENT. THE CURRENT FAILURE RATE IS WITHIN THE RISK ANALYSIS AND THEREFORE ACCEPTABLE. CONCLUSION: A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE. THERE IS NO INDICATION OF A MATERIAL DEFECT, MANUFACTURING FAILURE, OR DESIGN ERROR ON THE BASIS OF THE DEVICE HISTORY RECORD. FOR FURTHER INVESTIGATION, EXAMINATION OF THE COMPLAINT DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THIS CASE IS FILED UNDER INTERNAL REFERENCE: (B)(4). THE LEADING DEVICE CHANGED TO NR890M - ENDURO MENISCAL COMPONENT F3 10MM. INVOLVED COMPNENTS: NR860Z- AS ENDURO LOCKING NUT F/ROTATION AXIS. NR400K - NUT F/FEMUR EXTENS. STEM ALL SIZES NEUTR. NR193K - TIBIA OFFSET STEM D18X52MM CEMENTED. NR293K - FEMUR EXTENS. STEM 6° D18X77MM CEMENTED. NB019K - ENDURO FEMORAL COMPONENT CEMENTED F3R. NB013K - ENDURO TIBIAL COMP. OFFSET CEMENTED T3.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AE-QAS-K521-55 - COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE. THE ARTICLE CODE OF THE AFFECTED DEVICE IS UNKNOWN. ACCORDING TO THE COMPLAINT DESCRIPTION, THE AXLE OF THE DEVICE FRACTURED POST SURGERY. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172879 ENDURO MENISCAL COMPONENT F3 10MM KNEE ENDOPROSTHESES KRO AESCULAP AG NR890M 52395911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention