BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMIC

    MDR report key: 13202715 · Received January 10, 2022

    Report

    Report Number
    3009590742-2022-00001
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    December 2, 2019
    Report Date
    January 10, 2022
    Manufacturer
    AMPLITUDE
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RAW MATERIAL CERTIFICATE ATTESTS THAT THE RAW MATERIAL OF THE TIBIAL BASE PLATE COMPLIES WITH THE ISO 5832-4 STANDARD. THE REVIEW OF THE MANUFACTURING HISTORY RECORDS SHOWS THAT THE TIBIAL BASE PLATE AND THE INSERT HAVE BEEN MANUFACTURED ACCORDING TO OUR SPECIFICATIONS AND DRAWINGS. THE TIBIAL BASE PLATE HAS BEEN INSPECTED DURING MANUFACTURING PROCESS AND NO ANOMALY WAS DETECTED. THE REVIEW OF THE SALES DATA SHOWS THAT THE TOTALITY OF THE BATCH WAS IMPLANTED WITHOUT ANY OTHER INCIDENT REPORTED THE REVIEW OF THE INTERNAL VIGILANCE DATABASE REVEALS NO SIMILAR INCIDENT RELATED TO A LOOSENING OF THE ANATOMIC TIBAIL BASE PLATE CEMENTED. DESPITE SEVERAL EXCHANGE WITH THE HEALTHCARE FACILITY, NO ADDITIONAL INFORMATION COULD BE PROVIDED. WITHOUT THE EXTRA INFORMATION (EXPLANTED DEVICES, OPERATIVE REPORT, X-RAYS...), THE VISUAL AND DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED. IN CONCLUSION AND ACCORDING TO THE ELEMENTS IN OUR POSSESSION, THE ORIGIN OF THE INCIDENT CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    LOOSENING OF THE ANATOMIC® CEMENTED TIBIAL BASE PLATE FOR FIXED BEARING INSERT CEMENTED 66 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) 2014. DURING THE PATIENT CLINICAL MONITORING BY THE SURGEON ON (B)(6) 2018, THE SURGEON HAD REPORTED A POSSIBLE LOOSENING THE TIBIAL BASE PLATE. ASSOCIATED DEVICES: ANATOMIC® FIXED BEARING INSERT SIZE 3 THICKNESS 14 (REFERENCE: 1-0204732 AND BATCH NUMBER: 162572). ANATOMIC FEMORAL COMPONENT SIZE 4 RIGHT (REFERENCE: 1-0204504 AND BATCH NUMBER: NOT COMMUNICATED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169050 ANATOMIC ANATOMIC® TIBIAL BASE PLATE FOR FIXED BEARING INSERT CEMENTED JWH AMPLITUDE 1-0204903 211616

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention