BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO-MODEL SL KNEE JOINT PROSTHESIS

    MDR report key: 18719245 · Received February 16, 2024

    Report

    Report Number
    3004371426-2024-00011
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    January 11, 2024
    Report Date
    January 19, 2024
    Manufacturer
    WALDEMAR LINK GMBH & CO.KG
    Product Code
    KRO
    UDI-DI
    04026575383849
    PMA / PMN Number
    K151008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FINAL SUPPLEMENTAL REPORT, THE COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 0

    THIS IS THE FINAL SUPPLEMENTAL REPORT, THE COMPLAINT IS CLOSED.

    Description of Event or Problem · 0

    INFORMATION RECEIVED FROM SURGEON (B)(6) 2024 SUGGESTS THAT THE DESIGN OF THIS CONE AND STEM CONSTRUCT MAY NOT HAVE BEEN WELL SUITED FOR THIS PATIENT: THE SURGEON NOTED ON (B)(6) 2024 THAT THE WL CONES ADDRESS METAPHYSEAL AREA BUT DO NOT ADDRESS META-DIAPHYSEAL INGROWTH, ESPECIALLY WHEN USED WITH CEMENTLESS STEMS (AS IN THIS CASE). THE SUBJECT COMPONENTS WERE IMPLANTED BY DR. (B)(6) DURING REVISION KNEE SURGERY ON (B)(6) 2022. PATIENT COMPLAINED OF PAIN LOCATED IN MEDIAL AND LATERAL RIGHT KNEE STARTING AFTER SURGERY. DUE TO PAIN AND FEMORAL STEM LOOSENING, THE PATIENT'S KNEE WAS REVISED ON (B)(6) 2024. FEMORAL SIDE IMPLANTS WERE REPLACED WITH CUSTOM-MADE FEMORAL STEM (LBIO REF: CUS-736, WL REF: (B)(4)), AND STANDARD ITEMS 15-8521/10 (TOTAL CONDYLAR REPLACEMENT) AND 15-0027/15 (REPLACEMENT PLATEAU). [CUSTOMER].

    Description of Event or Problem · 0

    INFORMATION RECEIVED FROM SURGEON (B)(6) 2024 SUGGESTS THAT THE DESIGN OF THIS CONE AND STEM CONSTRUCT MAY NOT HAVE BEEN WELL SUITED FOR THIS PATIENT: THE SURGEON NOTED ON (B)(6) 2024 THAT THE WL CONES ADDRESS METAPHYSEAL AREA BUT DO NOT ADDRESS META-DIAPHYSEAL INGROWTH, ESPECIALLY WHEN USED WITH CEMENTLESS STEMS (AS IN THIS CASE). THE SUBJECT COMPONENTS WERE IMPLANTED BY DR. M. DURING REVISION KNEE SURGERY ON (B)(6) 2022. PATIENT COMPLAINED OF PAIN LOCATED IN MEDIAL AND LATERAL RIGHT KNEE STARTING AFTER SURGERY. DUE TO PAIN AND FEMORAL STEM LOOSENING, THE PATIENT'S KNEE WAS REVISED ON (B)(6) 2024. FEMORAL SIDE IMPLANTS WERE REPLACED WITH CUSTOM-MADE FEMORAL STEM (LBIO REF: (B)(6), WL REF: CASE 2023_0468), AND STANDARD ITEMS (B)(6) (TOTAL CONDYLAR REPLACEMENT) AND (B)(6) (REPLACEMENT PLATEAU). [CUSTOMER]

    Description of Event or Problem · 0

    INFORMATION RECEIVED FROM SURGEON 18-JAN-2024 SUGGESTS THAT THE DESIGN OF THIS CONE AND STEM CONSTRUCT MAY NOT HAVE BEEN WELL SUITED FOR THIS PATIENT: THE SURGEON NOTED ON (B)(6) 2024 THAT THE WL CONES ADDRESS METAPHYSEAL AREA BUT DO NOT ADDRESS META-DIAPHYSEAL INGROWTH, ESPECIALLY WHEN USED WITH CEMENTLESS STEMS (AS IN THIS CASE). THE SUBJECT COMPONENTS WERE IMPLANTED BY DR. (B)(6) DURING REVISION KNEE SURGERY ON (B)(6) 2022. PATIENT COMPLAINED OF PAIN LOCATED IN MEDIAL AND LATERAL RIGHT KNEE STARTING AFTER SURGERY. DUE TO PAIN AND FEMORAL STEM LOOSENING, THE PATIENT'S KNEE WAS REVISED ON (B)(6) 2024. FEMORAL SIDE IMPLANTS WERE REPLACED WITH CUSTOM-MADE FEMORAL STEM (LBIO REF: (B)(4), WL REF: CASE (B)(4)), AND STANDARD ITEMS 15-8521/10 (TOTAL CONDYLAR REPLACEMENT) AND 15-0027/15 (REPLACEMENT PLATEAU). [CUSTOMER]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2587034 ENDO-MODEL SL KNEE JOINT PROSTHESIS MODULAR STEM, UNCEMENTED, MALE TAPER, TI6AL4V, CONICAL, L=160 MM, Ø19 / 14 MM KRO WALDEMAR LINK GMBH & CO.KG 15-8522/57 2130188 04026575383849

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention