BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO-MODEL SL KNEE PROSTHESIS SYSTEM CONNECTION COMPONENT, ROTATIONAL VERSION

    MDR report key: 8053388 · Received November 8, 2018

    Report

    Report Number
    3006721341-2018-00005
    Event Type
    Injury
    Date Received
    November 8, 2018
    Date of Event
    October 30, 2018
    Report Date
    October 31, 2018
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED THIS REPORT TO INCLUDE A4: 252 LBS AND CHANGE B4: FROM 11/08/2018 TO 10/31/2018.

    Description of Event or Problem · 0

    ON NOV 08, 2018 LINKBIO COMPLAINTS TEAM WAS PROVIDED WITH ALL THE COMPLAINT DETAILS REGARDING THE REVISION SURGERY CONDUCTED ON (B)(6) 2018 TO EXPLANT A DISLOCATED CONNECTION COMPONENT (CATALOG # 16-2840/02, SN # (B)(4)) THAT WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2018. THE DEFECTIVE CONNECTION COMPONENT WAS REPLACED WITH A NEW CONNECTION COMPONENT DURING THE REVISION SURGERY (CATALOG # 16-2840/02, SN # (B)(4)).

    Description of Event or Problem · 1

    ON NOV 08, 2018 LINKBIO COMPLAINTS TEAM WAS PROVIDED WITH ALL THE COMPLAINT DETAILS REGARDING THE REVISION SURGERY CONDUCTED ON (B)(6) 2018 TO EXPLANT A DISLOCATED CONNECTION COMPONENT (CATALOG # 16-2840/02, SN # (B)(4)) THAT WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2018. THE DEFECTIVE CONNECTION COMPONENT WAS REPLACED WITH A NEW CONNECTION COMPONENT DURING THE REVISION SURGERY (CATALOG # 16-2840/02, SN # (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890488 ENDO-MODEL SL KNEE PROSTHESIS SYSTEM CONNECTION COMPONENT, ROTATIONAL VERSION ROTATING HINGED TOTAL KNEE PROSTHESIS KRO WALDEMAR LINK GMBH & CO. KG 16-2840/02

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention