BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 R

    MDR report key: 9494243 · Received December 19, 2019

    Report

    Report Number
    3005180920-2019-01090
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819391
    PMA / PMN Number
    K123721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON DECEMBER 12 2019: LOT 1902920: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ALL AVAILABLE ITEMS OF LOT 1902920 HAVE BEEN RE-INSPECTED AND VERIFIED TO BE IN COMPLIANCE WITH THE SPECIFICATIONS. THE CASE IS ISOLATED TO ONLY ONE PIECE OF THE LOT. VISUAL INSPECTION PERFORMED BY R&D KNEE MANAGER: DURING REVISION SURGERY, AFTER HAVING ALREADY CEMENTED ALL THE TIBIA SEMI-CONSTRAINED CONSTRUCT (BASEPLATE, CONE, OFFSET, STEM, AND MEDIAL/LATERAL TIBIAL AUGMENTS), THE SURGEON TRIED TO ASSEMBLE THE SEMI-CONSTRAINED INSERT. THE INSERT COULDN'T COMPLETELY ENGAGE IT INTO THE BASEPLATE. THE SURGEON TRIED ANOTHER 2 TIMES WITH 2 NEW TIBIAL INSERTS WITHOUT SUCCESS. THE SURGEON THEN OBSERVED INTRAOPERATIVELY THAT THE TIBIA BASEPLATE POSTERIOR LOCKING MECHANISM WAS NOT MACHINED. FROM VISUAL INSPECTION OF THE RETURNED TIBIAL BASEPLATE, WE CAN CONFIRM THAT THE POSTERIOR FEATURES FOR THE LOCKING MECHANISM OF THE TIBIAL INSERT ARE PARTIALLY MACHINED. FROM FUNCTIONAL INSPECTION WITH DEDICATED GAUGE, IT IS POSSIBLE TO CONFIRM THAT THE INSERT COULD NOT ENGAGE IN THE BASEPLATE. THE ROOT CAUSE FOR INCOMPLETE MACHINING OF THE POSTERIOR LOCKING MECHANISM IS RELATED TO A MILLING TOOL BREAKAGE DURING MACHINING FOLLOWED BY INEFFECTIVE / INCOMPLETE CONTAINMENT AND INSPECTION OF THE EFFECTED UNIT.

    Description of Event or Problem · 1

    THE SURGEON ATTEMPTED TO LOCK THE SEMI-CONSTRAINED POLY INTO THE TIBIA BUT IT WAS NOT POSSIBLE. AFTER 20 MINUTES, THE AGENT OPENED UP ANOTHER SEMI-CONSTRAINED POLY FOR THE SURGEON TO USE, AND THAT DID NOT LOCK IN EITHER. THE AGENT OPENED THEN A PS POLY AND IT DIDN'T SEAT EITHER. THE SURGEON OBSERVED THAT THE TIBIA BASEPLATE LOCKING MECHANISM WASN'T MACHINED IN TO HAVE THE POLY LOCKED INTO IT. THE SURGEON DECIDED AT THIS POINT TO EXPLANT THE WHOLE TIBIAL CONSTRUCT (BASEPLATE, CONE, OFFSET, STEM, AND MEDIAL/LATERAL TIBIAL AUGMENTS) AND REPLACED THE COMPONENTS WITH A NEW BASEPLATE, CONE, OFFSET, STEM, AND MEDIAL/LATERAL TIBIAL AUGMENTS, AND UPSIZED TIBIAL BASEPLATE AND A SEMI-CONSTRAINED POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A 50-MINUTE DELAY IN THE CASE. ADDITIONAL ANAESTHESIA WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287600 GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 R TIBIAL TRAY FIXED JWH MEDACTA INTERNATIONAL SA 1902920 07630030819391

    Patients

    Seq Age Sex Outcome Treatment
    1 Other