BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMIC

    MDR report key: 16239365 · Received January 25, 2023

    Report

    Report Number
    3009590742-2023-00001
    Event Type
    Injury
    Date Received
    January 25, 2023
    Date of Event
    January 1, 2019
    Report Date
    January 25, 2023
    Manufacturer
    AMPLIUTUDE
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF MANUFACTURING DATA SHOWS THAT: THE RAW MATERIAL OF THE ANATOMIC FIXED BEARING INSERT COMPLIES WITH ISO 5834-2 STANDARD. THE REVIEW OF THE MANUFACTURING HISTORY RECORDS SHOWS THAT THE DEVICES HAVE BEEN MANUFACTURED ACCORDING TO OUR SPECIFICATIONS AND DRAWINGS. THE PARTS HAVE BEEN INSPECTED DURING MANUFACTURING PROCESS AND NO ANOMALY WAS DETECTED. THE REVIEW OF THE INTERNAL VIGILANCE DATABASE DOESN'T SHOW SIMILAR INCIDENT RELATED TO POST-OPERATIVE INSTABILITY OF THE ANATOMIC FIXED BEARING INSERT. THE ANALYSIS OF THE RECORDED PATIENT FILE DURING THE PATIENT CLINICAL MONITORING BY THE SURGEON DOESN'T REVEAL ANY ELEMENTS WHICH COULD EXPLAIN THE POST-OPERATIVE INSTABILITY WITH AN ANATOMIC FIXED BEARING INSERT. IT WAS NOTED THAT A FIRST REVISION OF THE ANATOMIC FIXED BEARING INSERT (REPLACEMENT OF A THICKNESS 12 FOR A THICKNESS 16) HAS BEEN PERFORMED 7 MONTHS AFTER THE IMPLANTATION FOR A FRONTAL LAXITY WITH A RECURVATUM EXCESS. IT WAS NOTED THAT THE PATIENT HAS SEVERE OBESITY CLASS II (BMI : 36.7). WITHOUT EXPLANT, X-RAYS, NO FURTHER INVESTIGATION CAN BE PERFORMED. IN CONCLUSION AND ACCORDING TO THE ELEMENTS IN OUR POSSESSION, THE ORIGIN OF THE INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    NO REVIEW OF MANUFACTURING HISTORY RECORDS COULD BE PERFORMED AS THE LIST OF DEVICES WAS NOT COMMUNICATED BY THE HEALTHCARE FACILITY. THE REVIEW OF THE INTERNAL VIGILANCE DATABASE SHOW 1 SIMILAR INCIDENT RELATED TO POST-OPERATIVE PAIN OF THE ANATOMIC TOTAL KNEE PROSTHESIS. THE ANALYSIS OF THE RECORDED PATIENT FILE DURING THE PATIENT CLINICAL MONITORING BY THE SURGEON DOESN'T REVEAL ANY ELEMENTS WHICH COULD EXPLAIN THE POST-OPERATIVE PATIENT PAIN WITH AN ANATOMIC TOTAL KNEE PROSTHESIS. THE RATE IS 0.0020%. IT WAS NOTED THAT THE PATIENT HAS SEVERE OBESITY CLASS II (BMI : 36.7). WITHOUT EXPLANT, REFERENCE, BATCH NUMBER, X-RAYS, NO FURTHER INVESTIGATION CAN BE PERFORMED. IN CONCLUSION AND ACCORDING TO THE ELEMENTS IN OUR POSSESSION, THE ORIGIN OF THE UNEXPLAINED PAIN AFTER 1 YEAR AND 10 MONTHS REMAINS UNDETERMINED.

    Description of Event or Problem · 0

    ACCORDING TO REPORTER FEEDBACK, THE INCIDENT REPORTED IS AN PATIENT INSTABILITY INSTEAD OF UNEXPLAINED PAIN REPORTED INITIALLY AFTER AN IMPLANTATION IN (B)(6) 2017 OF A ANATOMIC TOTAL KNEE PROSTHESIS, IT WAS REPORTED IN (B)(6) 2017 A REPLACEMENT SURGERY OF THE ANATOMIC FIXED BEARING INSERT SIZE 2 THICKNESS 12 (REFERENCE: *(B)(4), BATCH NUMBER: 242441) BY AN ANATOMIC FIXED BEARING INSERT SIZE 2 THICKNESS 16 DUE TO PATIENT INSTABILITY. IT WAS REPORTED IN (B)(6) 2019 A REVISION SURGERY OF THE TOTAL KNEE PROSTHESIS ANATOMIC DUE TO PATIENT INSTABILITY WITH LAXITY IN EXTENSION. THESE INCIDENTS WERE REPORTED DURING THE PATIENT CLINICAL MONITORING BY THE SURGEON. INVOLVED DEVICES: ANATOMIC FIXED BEARING INSERT SIZE 2 THICKNESS 12 (REFERENCE (B)(4), BTACH NUMBER 242441); ANATOMIC FIXED BEARING INSERT SIZE 2 THICKNESS 16 (REFERENCE (B)(4), BATCH NUMBER 206504); ANATOMIC TIBIAL BASEPLATE FOR FIXED BEARING INSERT CEMENTED SIZE 2 (REFERENCE (B)(4), BATCH NUMBER 250770); ANATOMIC POSTERIOR STABILIZED FEMORAL COMPONENT CEMENTED SIZE 2 RIGHT (REFERENCE (B)(4), BATCH NUMBER 257339).

    Description of Event or Problem · 0

    UNEXPLAINED PAIN ON TOTAL KNEE PROSTHESIS ANATOMIC 1 YEAR AND 10 MONTHS AFTER THE IMPLANTATION. THE INCIDENT WAS DETECTED DURING THE PATIENT CLINICAL MONITORING BY THE SURGEON ON (B)(6) 2019. THE IMPLANTATION WAS PERFORMED ON (B)(6) 2017. INVOLVED DEVICES: ANATOMIC® POSTERIOR STABILIZED FEMORAL COMPONENT CEMENTED SIZE 2 (REFERENCE AND BATCH NUMBER NOT COMMUNICATED). ANATOMIC® FIXED BEARING INSERT SIZE 1 THICKNESS 12MM (REFERENCE AND BATCH NUMBER NOT COMMUNICATED). ANATOMIC® TIBIAL BASE PLATE FOR FIXED BEARING INSERT CEMENTED SIZE 1 (REFERENCE AND BATCH NUMBER NOT COMMUNICATED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769934 ANATOMIC ANATOMIC FIXED BEARING INSERT JWH AMPLIUTUDE 1-0204723 206504

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention