BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO-MODEL MODULAR KNEE SYSTEM

    MDR report key: 14488676 · Received May 24, 2022

    Report

    Report Number
    3004371426-2022-00013
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Date of Event
    April 22, 2022
    Report Date
    May 24, 2022
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    KRO
    PMA / PMN Number
    K212742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS NOT AFFECTED BY R-2022-01 FOR THE SCREW ISSUES. A CAPA IS INITIATED TO REVIEW THE ASSEMBLY PROCESS OF THE SREWS.

    Description of Event or Problem · 0

    AS REPORTED: SCREW FOR HEMI AUGMENTS ON TIBIAL BASEPLATE COULD NOT BE REMOVED FROM IMPLANT; THREE SEPARATE BASEPLATES WERE OPENED. THE PRELOADED SCREW THAT NEEDS TO BE REMOVED TO ACCOMMODATE A HEMI WEDGE AUGMENT WOULD NOT COME OUT. SOME ADDITIONAL INFORMATION (B)(6) RECEIVED ON (B)(6) 2022: THIS WAS A BILATERAL SURGERY, DOCTOR OPENED BOTH LEFT AND RIGHT PRODUCT. ONE HOUR OF SURGICAL TIME WAS ADDED TO THE FIRST KNEE AND 40MINUTES WERE ADDED TO THE 2ND KNEE. UPDATED 2022-05-04: ATTACHED PRODUCTS DELIVERED FORM. AND INFORMATION UPDATED ON PHONE CALL (B)(6) ON (B)(6) 2022, THAT THE "SCREWDRIVER USED WOULD HAVE BEEN A 2.5 HEX THAT COMES WITH THE SET". NO OTHER INFORMATION HAS BEEN RECEIVED. UPDATED 2022-05-18: AFTER INQUIRING (B)(6) ABOUT WHETHER THE SAME ISSUE WAS PRESENT WITH ALL 3 TIBIAL BASEPLATES WHICH WERE OPENED, HIS RESPONSE WAS THAT YES, ALL HAD THE SAME SCREW ISSUE. HE ALSO STATED THAT 4 BASE PLATES WERE OPENED (SEE PRODUCT DELIVERED GOODS FORM) AS THIS WAS A BILATERAL SURGERY AND THE 3 DOCUMENTED IN THIS COMPLAINT HAD SCREWS THAT WERE STUCK, BUT THEY DRILLED OUT ONE OF THE SCREWED AND IMPLANTED IT WITH THE AUGMENTS. HE REPORTED THAT THE PATIENT WAS DOING FINE. REVIEW OF THE PDGF SHOWS LOT CODE 170109/1762 (LEFT) AS IMPLANTED (THIS IS ASSUMED TO BE THE DRILLED OUT PLATE), AND (RIGHT) 15-3817/11 LOT 210322/0136, ALSO AS IMPLANTED, NO ISSUES WITH SCREWS.

    Description of Event or Problem · 0

    AS REPORTED: SCREW FOR HEMI AUGMENTS ON TIBIAL BASEPLATE COULD NOT BE REMOVED FROM IMPLANT; THREE SEPARATE BASEPLATES WERE OPENED. THE PRELOADED SCREW THAT NEEDS TO BE REMOVED TO ACCOMMODATE A HEMI WEDGE AUGMENT WOULD NOT COME OUT. SOME ADDITIONAL INFORMATION FROM J. T., RECEIVED 2022-04-28: THIS WAS A BILATERAL SURGERY, DOCTOR OPENED BOTH LEFT AND RIGHT PRODUCT. ONE HOUR OF SURGICAL TIME WAS ADDED TO THE FIRST KNEE AND 40MINUTES WERE ADDED TO THE 2ND KNEE. UPDATED 2022-05-04: ATTACHED PRODUCTS DELIVERED FORM. AND INFORMATION UPDATED ON PHONE CALL WITH J. T. FROM 2022-04- 28, THAT THE "SCREWDRIVER USED WOULD HAVE BEEN A 2.5 HEX THAT COMES WITH THE SET". NO OTHER INFORMATION HAS BEEN RECEIVED. UPDATED 2022-05-18: AFTER INQUIRING M. M. ABOUT WHETHER THE SAME ISSUE WAS PRESENT WITH ALL 3 TIBIAL BASEPLATES WHICH WERE OPENED, HIS RESPONSE WAS THAT YES, ALL HAD THE SAME SCREW ISSUE. HE ALSO STATED THAT 4 BASE PLATES WERE OPENED (SEE PRODUCT DELIVERED GOODS FORM) AS THIS WAS A BILATERAL SURGERY AND THE 3 DOCUMENTED IN THIS COMPLAINT HAD SCREWS THAT WERE STUCK, BUT THEY DRILLED OUT ONE OF THE SCREWED AND IMPLANTED IT WITH THE AUGMENTS. HE REPORTED THAT THE PATIENT WAS DOING FINE. REVIEW OF THE PDGF SHOWS LOT CODE 170109/1762 (LEFT) AS IMPLANTED (THIS IS ASSUMED TO BE THE DRILLED OUT PLATE), AND (RIGHT) 15-3817/11 LOT 210322/0136, ALSO AS IMPLANTED, NO ISSUES WITH SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208184 ENDO-MODEL MODULAR KNEE SYSTEM ENDO-MODEL - M, ROTATIONAL KNEE PROSTHESIS, KNEE-JOINT PROSTHESIS KRO WALDEMAR LINK GMBH & CO. KG 15-3817/12

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other