BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT SIZE 2-RIGHT MED 11MM

    MDR report key: 17011790 · Received May 26, 2023

    Report

    Report Number
    1020279-2023-01152
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    May 7, 2021
    Report Date
    May 31, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NJD
    UDI-DI
    00885556873373
    PMA / PMN Number
    K190439
    Removal / Correction Number
    RES 92286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: RESULTS OF INVESTIGATION: IT WAS REPORTED THAT A SURGICAL RESIDENT WAS ALLOWED TO PERFORM THE TIBIAL RESECTION STEP ON THE PATIENT. THE SURGICAL RESIDENT HAD NOT BEEN TRAINED ON THE PROPER ENGAGE SURGICAL TECHNIQUE OR USE OF THE INSTRUMENTS AND WAS NOT CERTIFIED BY ENGAGE TO USE THE SYSTEM. THE ATTENDING SURGEON REPORTED THAT A VERY ¿AGGRESSIVE¿ TIBIAL CUT WAS MADE BY THE RESIDENT AT THE TIME OF SURGERY. POSTOP X-RAY REVEALED A SUPER-PHYSIOLOGIC POSTERIOR SLOPE OF 19 DEG WAS MEASURED WHEN USED PROPERLY THE INSTRUMENTS PRODUCE A 5 DEG NOMINAL POSTERIOR SLOPE, WHICH HAS BEEN SHOWN TO BE CLINICALLY SUCCESSFUL IN OTHER PARTIAL KNEE REPLACEMENT SYSTEMS. AN ABNORMALLY HIGH POSTERIOR SLOPE WOULD LEAD TO ELEVATED TIBIAL STRAINS BEING INTRODUCED INTO THE BONE AS WELL AS ADDITIONAL STRESSES BEING APPLIED TO THE ACL. THE X-RAYS REVEALED NO FAILURE OR MALFUNCTION OF THE DEVICE. DEVICES APPEAR WELL-APPROXIMATED TO THE BONE WITH NORMAL IN-GROWTH EVIDENT AT 7-MO ON CT EVALUATION. THERE WAS NO INJURY TO THE PATIENT RELATED TO THE DEVICE, AS THE REVISION WAS DUE TO USE BY AN UN-TRAINED USER. THE PATIENT WAS SUCCESSFULLY REVISED TO A TKA AT 8-MONTHS POST-OP. THE SURGEON AND REP REPORTED THAT THE IMPLANTS WERE WELL-FIXED TO THE BONE PRIOR TO REMOVAL. INVESTIGATION UPDATE: AS CORRECTION ACTION A VOLUNTARY MARKET REMOVAL WILL BE PERFORMED FOR THE ENGAGE CEMENTLESS PARTIAL KNEE SYSTEM DUE RECENT COMPLAINT DATA THAT INDICATES THAT THE REVISION RATE MAY BE TRENDING HIGHER THAN CORRESPONDING SIMILAR DEVICES IN GLOBAL JOINT REPLACEMENT REGISTRIES. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCTS FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION MAY BE INDICATED.

    Additional Manufacturer Narrative · 0

    SMITH & NEPHEW, INC., HAS INITIATED A FIELD ACTION TO VOLUNTARILY REMOVE THE ENGAGE CEMENTLESS PARTIAL KNEE SYSTEM FROM THE MARKET. THIS COMPLAINT WAS ORIGINALLY PROCESSED IN THE ENGAGE SURGICAL COMPLAINT MANAGEMENT SYSTEM PRIOR TO ACQUISITION BY SMITH & NEPHEW, INC. THE EVENT HAS BEEN REASSESSED AND IS BEING RETROSPECTIVELY REPORTED IN ASSOCIATION WITH THE FIELD ACTION. ADDITIONALLY, THE INVESTIGATION OF THIS INCIDENT PREVIOUSLY CONDUCTED BY ENGAGE SURGICAL HAS BEEN RE-OPENED FOR REVIEW. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON COMPLETION OF FURTHER INVESTIGATION ACTIVITIES BY SMITH & NEPHEW, INC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, SIX MONTHS AFTER UNICOMPARTMENTAL KNEE ARTHROPLASTY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY TO TKA ON (B)(6) 2021. AN ABNORMALLY HIGH POSTERIOR SLOPE OF 19 DEGREES (THE STANDARD IS 5 DEGREES) WAS PRODUCED UPON TIBIAL RESECTION, WHICH IS THE PROBABLE ROOT CAUSE THE REPORTED PAIN. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729479 TIBIAL INSERT SIZE 2-RIGHT MED 11MM PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, NJD SMITH & NEPHEW, INC. 100084 00885556873373

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other PN: 1-10003-200 / LOT: 100021| PN: 1-10011-100 / LOT: 100069| PN: 1-10012-250 / LOT: 100048