BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMIC

    MDR report key: 24698733 · Received March 26, 2026

    Report

    Report Number
    3009590742-2026-00002
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    February 17, 2026
    Manufacturer
    AMPLITUDE
    Product Code
    JWH
    PMA / PMN Number
    K161414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE MANUFACTURING DATA SHOW THAT: - THE RAW MATERIAL OF THE ANATOMIC INSERT COMPLIES WITH THE ISO 5834-1-2 STANDARD. - THE REVIEW OF THE MANUFACTURING HISTORY RECORDS SHOWS THAT THE DEVICES WERE MANUFACTURED ACCORDING TO OUR SPECIFICATIONS AND DRAWINGS. - 100% OF THE PARTS WERE INSPECTED DURING MANUFACTURING PROCESS AND NO ANOMALY WAS DETECTED. THE REVIEW OF THE INTERNAL VIGILANCE DATABASE REVEALS THAT NO OTHER INCIDENT WAS REPORTED RELATED TO THE SAME BATCH NUMBER OF ANATOMIC TKA COMPONENT. THE REVIEW OF THE INTERNAL VIGILANCE DATABASE SINCE 2014 REVEALS THAT THE INCIDENT OCCURENCE RATE RELATED TO LOOSENING OF ANATOMIC CEMENTED TIBIAL BASEPLATE IS RARE. THE REVIEW OF THE INTERNAL VIGILANCE DATABASE SINCE 2014 REVEALS THAT THE INCIDENT OCCURENCE RATE RELATED TO LOOSENING OF ANATOMIC CEMENTED POSTERIOR STABILIZED FEMORAL COMPONENT IS RARE. THE REVIEW OF THE INTERNAL VIGILANCE DATABASE SINCE 2014 REVEALS THAT THE INCIDENT OCCURENCE RATE RELATED TO WEAR OF ANATOMIC FIXED BEARING INSERT IS RARE. THE DECLARANT HAS NOT PROVIDED ANY INFORMATION THAT WOULD ENABLE FURTHER INVESTIGATIONS TO BE CARRIED OUT (THE ANATOMIC TKA EXPLANT WAS NOT RETURNED BY THE HEALTHCARE FACILITY. NO X-RAYS. NO OPERATIVE REPORT. NO INFORMATION RELATED TO PATIENT (BMI, ACTIVITY). IN CONCLUSION, ORIGINE OF INSERT ANORMAL WEAR AND LOOSENING REPORTED CANNOT BE ESTABLISHED AFTER 7 YEARS OF IMPLANTATION.

    Description of Event or Problem · 0

    TKA ANATOMIC LOOSENING WAS REPORTED ASSOCIATED WITH ABNORMAL WEAR OF ANATOMIC INSERT AFTER 7 YEARS OF IMPLANTATION. INVOLVED DEVICES : ANATOMIC POSTERIOR STABILIZED FEMORAL COMPONENT CEMENTED SIZE 3 LEFT (REFERENCE: (B)(4), LOT NUMBER: 279526). ANATOMIC TIBIAL BASE PLATE FOR FIXED BEARING INSERT CEMENTED SIZE 2 (REFERENCE: (B)(4), LOT NUMBER: 279789). ANATOMIC FIXED BEARING INSERT SIZE 2 THICKNESS 12 MM (REFERENCE: (B)(4), LOT NUMBER: 212737).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762056 ANATOMIC ANATOMIC FIXED BEARING INSERT JWH AMPLITUDE 1-0204603 279526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention