BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINK ENDO-MODEL ROTATION KNEE JOINT PROSTHESIS WITH POREX SURFACE MODIFICATION

    MDR report key: 8978841 · Received September 10, 2019

    Report

    Report Number
    3004371426-2019-00127
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    December 23, 2015
    Report Date
    July 7, 2017
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    KRO
    PMA / PMN Number
    K152431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARTICLE FROM THIS CASE 15-9024/12 AND SN (B)(4) WAS INVESTIGATED AND EVALUATED INITIALLY UNDER THE REFERENCE (B)(4) (MDR 3004371426-2019-00069). AT THAT TIME WE WERE PROVIDED WITH A WRONG COMPLAINT SAMPLE. NOW THE CORRECT SAMPLE (15-8030/11 SN (B)(4)) WAS SENT AND EVALUATED UNDER (B)(4) AND MDR 3004371426-2019-00069. SO A NEW REFERENCE NUMBER WAS ASSIGNED FOR THE TINBN KNEE (15-9024/12 AND SN (B)(4)) AND COMPLETED UNDER (B)(4) AND MDR 3004371426-2019-00127.

    Description of Event or Problem · 1

    [TRANSLATION]: BUSHING FAILURE AFTER 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773941 LINK ENDO-MODEL ROTATION KNEE JOINT PROSTHESIS WITH POREX SURFACE MODIFICATION ROTATING HINGED TOTAL KNEE PROSTHESIS KRO WALDEMAR LINK GMBH & CO. KG 15-9024/12

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention