BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO-MODEL- M, ROTATIONAL KNEE PROSTHESIS

    MDR report key: 17602033 · Received August 23, 2023

    Report

    Report Number
    3004371426-2023-00079
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    January 6, 2023
    Report Date
    July 26, 2023
    Manufacturer
    WALDEMAR LINK GMBH & CO.KG
    Product Code
    KRO
    UDI-DI
    04026575034741
    PMA / PMN Number
    K212742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. THE PRODUCT COMPLIES WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE.

    Additional Manufacturer Narrative · 0

    THE REWIEV OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. THE PRODUCT COMPLIES WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 0

    TINBN-COATED HINGED KNEE WAS IMPLANTED (B)(6) 2022 AS A TEMPORARY SPACER FOR THE 1ST STAGE IN A PLANNED 2 STAGE REVISION FOR INFECTION. THIS TINBN-COATED HINGED KNEE WAS USED AS A SPACER BECAUSE OF THE PATIENT'S NICKEL ALLERGY. THE PATIENT UNDERWENT REVISION SURGERY (B)(6) 2022. THE FEMORAL COMPONENT, TIBIAL POLYETHYLENE BEARING, AND FEMORAL AUGMENT WERE REPLACED (IMPACTED ONTO THE EXISTING FEMORAL STEM IN SITU). PRIOR SURGERIES ON THIS KNEE INCLUDE: PRIMARY AND REVISION TKA (NOT LINK PRODUCT), REVISION WITH LINK COMPASSIONATE USE COMPONENTS (B)(6) 2022 (B)(4), AND SUBSEQUENT REVISIONS (B)(6) 2022 AND (B)(6) 2022 FOR INFECTION (PREVIOUSLY REPORTED IN COMPLAINT (B)(4). [CUSTOMER].

    Description of Event or Problem · 0

    TINBN-COATED HINGED KNEE WAS IMPLANTED (B)(6) 2022 AS A TEMPORARY SPACER FOR THE 1ST STAGE IN A PLANNED 2 STAGE REVISION FOR INFECTION. THIS TINBN-COATED HINGED KNEE WAS USED AS A SPACER BECAUSE OF THE PATIENT'S NICKEL ALLERGY. THE PATIENT UNDERWENT REVISION SURGERY (B)(6) 2022. THE FEMORAL COMPONENT, TIBIAL POLYETHYLENE BEARING, AND FEMORAL AUGMENT WERE REPLACED (IMPACTED ONTO THE EXISTING FEMORAL STEM IN SITU). PRIOR SURGERIES ON THIS KNEE INCLUDE: PRIMARY AND REVISION TKA (NOT LINK PRODUCT), REVISION WITH LINK COMPASSIONATE USE COMPONENTS 2022-08-10 (COMP-053), AND SUBSEQUENT REVISIONS 2022-09-26 AND 2022-10-07 FOR INFECTION (PREVIOUSLY REPORTED IN COMPLAINT 2022-053) AND FOR DISSOCIATION OF FEMORAL COMPONENT FROM STEM (SAME STEM AS PREVIOUS EVENT IN COMPLAINT 2023-060). [CUSTOMER]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496653 ENDO-MODEL- M, ROTATIONAL KNEE PROSTHESIS KNEE-JOINT PROSTHESIS RIGHT, SMALL, COCRMO/TINBN, WITH PATELLAR FLANGE KRO WALDEMAR LINK GMBH & CO.KG 15-3816/11#02 04026575034741

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention