BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMIC

    MDR report key: 23298900 · Received October 15, 2025

    Report

    Report Number
    3009590742-2025-00005
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 29, 2023
    Report Date
    October 15, 2025
    Manufacturer
    AMPLITUDE
    Product Code
    JWH
    PMA / PMN Number
    K161414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO REVIEW OF MANUFACTURING DATA COULD BE PERFORMED AS THE LIST OF DEVICES AND LOT NUMBERS WERE NOT COMMUNICATED. THE REVIEW OF THE INTERNAL VIGILANCE DATABASE SHOWS A TOTAL OF 6 INCIDENTS RELATED TO POST-OPERATIVE PAIN WITH ANATOMIC PROTHESIS (CEMENTED OR CEMENTLESS). THE OCCURRENCE IS RARE (BASED ON ANATOMIC FEMORAL COMPONENT GLOBAL SALES BETWEEN AUGUST 2020 AND SEPTEMBER 2025). IT WAS NOTED THAT 4 INCIDENTS WERE REPORTED BY ONLY ANOTHER ONE HEALTHCARE FACILITY. THE ANALYSIS OF THE PATIENT FILE RECORDED DURING THE CLINICAL MONITORING PERFORMED BY THE SURGEON SHOW THAT THE PATIENT HAVE IRREDUCIBLE FLESSUM. THE PATIENT FILE DOESN'T REVEAL ANY OTHER ELEMENT WHICH COULD EXPLAIN THE POSTOPERATIVE PAIN 8 MONTHS AFTER THE IMPLANTATION. WITHOUT EXPLANTS, BATCH NUMBERS AND REFERENCE NUMBERS, X-RAYS, NO FURTHER INVESTIGATION CAN BE PERFORMED. IN CONCLUSION AND ACCORDING TO THE ELEMENTS IN OUR POSSESSION, THE ORIGIN OF THE POST-OPERATIVE PAIN AND IRREDUCTIBLE FLESSUM CANNOT BE EXPLAINED AND REMAINS UNKNOWN.

    Description of Event or Problem · 0

    UNEXPLAINED PAIN ON ANATOMIC TKA, 8 MONTHS AFTER THE IMPLANTATION. THE INCIDENT WAS DETECTED DURING THE PATIENT CLINICAL MONITORING BY THE SURGEON. IMPLANTATION PERFORMED ON (B)(6) 2023. INVOLVED DEVICE: ANATOMIC TIBIAL BASE PLATE FOR FIXED BEARING INSERT CEMENTED SIZE 3, (REFERENCE: 1-0204903, LOT NUMBER: UNKNOWN). ANATOMIC POSTERIOR STABILIZED FEMORAL COMPONENT CEMENTLESS - HA COATED SIZE 4 LEFT (REFERENCE: 1-0204404, LOT NUMBER: UNKNOWN). ANATOMIC FIXED BEARING INSERT SIZE 3 THICKNESS 10 MM (REFERENCE: 1-0204730, LOT NUMBER: UNKNOWN) EXTENSION STEM FOR TOTAL KNEE PROSTHESIS Ø 10 MM LG 75 MM (REFERENCE: 1-0200710, LOT NUMBER: UNKNOWN) RESURFACING PATELLAR IMPLANT CEMENTED Ø 36 MM (REFERENCE: 1-0200836, LOT NUMBER: UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2358533 ANATOMIC ANATOMIC FIXED BEARING INSERT JWH AMPLITUDE SIZE 3 NOT COMMUNICATED

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention