BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINK ENDO-MODEL® ROTATION KNEE JOINT PROSTHESIS - CEMENTABLE

    MDR report key: 8296672 · Received February 1, 2019

    Report

    Report Number
    3004371426-2019-00069
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    July 11, 2016
    Report Date
    June 23, 2017
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    KRO
    PMA / PMN Number
    K143179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE USER REPORT, THE ARTICLE IN QUESTION IS (B)(4),WHICH WAS ALSO STATED IN THE COMPLAINT REPORT, BUT THE TINBN KNEE WAS RETURNED WITH ARTICLE NUMBERS 15-9024/12 AND SN (B)(4) THE ARTICLE (B)(4) IS FILED AND INVESTIGATED UNDER (B)(4) (MDR 3004371426-2019-00069). THE ARTICLE (B)(4) AND SN (B)(4) IS NOW FILED AND INVESTIGATED UNDER (B)(4) (MDR 3004371426-2019-00127).

    Description of Event or Problem · 0

    TRANSLATION: ON (B)(6) 2016 THE PATIENT WAS EXAMINED DUE TO INCREASED PAIN AFTER THE LAST OPERATION WITH KNEE PROSTHESIS CHANGE ON (B)(6) 2010. THE KNEE JOINT BLOCKS WHEN STANDING UP AND STARTING UP. THE KNEE IS OVERSTRETCHED. THERE WAS A MEDIOLATERAL FOLDABILITY WITH UNPHYSIOLOGICAL JOINT PLAY IN THE SOCKET MECHANISM. THE RIGHT KNEE JOINT CAN ONLY BE BENT AGAINST SLIGHT RESISTANCE, A MECHANISM THAT RUNS WITH DIFFICULTY. AFTER EXPLANTATION OF THE PROSTHESIS ON (B)(6) 2016, A FRACTURE IN THE COUPLING MECHANISM/BUSHING DAMAGE TO THE PROSTHESIS WAS OBSERVED."

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE USER REPORT, THE ARTICLE IN QUESTION IS 15-8030/11 SN (B)(4), WHICH WAS ALSO STATED IN THE COMPLAINT REPORT, BUT THE TINBN KNEE WAS RETURNED WITH ARTICLE NUMBERS 15-9024/12 AND SN (B)(4). THE REPORT IS DELAYED DUE TO INCONSISTENCIES WITH REGARD TO FOREIGN EVENT REPORTING TO FDA. AFTER RE-EVALUATION OF THE COMPLAINT WE DETERMINED THAT IT IS REPORTABLE. WE HAVE ADDRESSED THE INCONSISTENCY IN REPORTING FOREIGN EVENTS TO FDA THROUGH CAPA-(B)(4).

    Description of Event or Problem · 1

    TRANSLATION: ON (B)(6) 2016 THE PATIENT WAS EXAMINED DUE TO INCREASED PAIN AFTER THE LAST OPERATION WITH KNEE PROSTHESIS CHANGE ON (B)(6) 2010. THE KNEE JOINT BLOCKS WHEN STANDING UP AND STARTING UP. THE KNEE IS OVER STRETCHABLE. THERE WAS A MEDIOLATERAL FOLDABILITY WITH UNPHYSIOLOGICAL JOINT PLAY IN THE SOCKET MECHANISM. THE RIGHT KNEE JOINT CAN ONLY BE BENT AGAINST SLIGHT RESISTANCE, A MECHANISM THAT RUNS WITH DIFFICULTY. AFTER EXPLANTATION OF THE PROSTHESIS ON (B)(6) 2016, A FRACTURE IN THE COUPLING MECHANISM/BUSHING DAMAGE TO THE PROSTHESIS WAS OBSERVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89831 LINK ENDO-MODEL® ROTATION KNEE JOINT PROSTHESIS - CEMENTABLE ROTATING HINGED TOTAL KNEE PROSTHESIS KRO WALDEMAR LINK GMBH & CO. KG 15-8030/11

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention