BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL ANCHOR STEM SIZE 3-4

    MDR report key: 17010869 · Received May 26, 2023

    Report

    Report Number
    1020279-2023-01139
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    July 12, 2021
    Report Date
    June 26, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NJD
    UDI-DI
    00885556873090
    PMA / PMN Number
    K190439
    Removal / Correction Number
    Z-1671-2023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6, H7, H9. RESULTS OF INVESTIGATION: BASED ON THE X-RAYS PROVIDED, IT APPEARS THAT THE IMPLANT WAS MAL POSITIONED WITH THE TRAY NOT FULLY SEATED ANTERIORLY. LOADING OF THE IMPLANT DURING NORMAL ACTIVITY WOULD RESULT IN HIGHER THAN NORMAL FORCES GENERATED ON THE ANCHOR COMPONENT, CAUSING A LEVERING EFFECT. A (B)(6) 2021 X-RAY CONFIRMED THE FRACTURED ANCHOR COMPONENT. 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, EIGHT MONTHS AFTER UNICOMPARTMENTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED PAIN. A POST-OPERATIVE X-RAY SHOWED RADIOLUCENCY AROUND THE ANCHOR AND FRACTURE OF THE ANCHOR. BASED ON THE X-RAYS PROVIDED, THE IMPLANT WAS MALPOSITIONED WITH THE TRAY NOT FULLY SEATED ANTERIORLY. LOADING OF THE IMPLANT DURING NORMAL ACTIVITY WOULD RESULT IN HIGHER THAN NORMAL FORCES GENERATED ON THE ANCHOR COMPONENT, CAUSING A LEVERING EFFECT. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY TO TKA ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609000 TIBIAL ANCHOR STEM SIZE 3-4 PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, NJD SMITH & NEPHEW, INC. 100070 00885556873090

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Hospitalization| R PN: 1-10012-450,POROUS TIBIAL SIZE 4-R,LOT:100050| PN:1-10003-500,POROUS FEM SIZE 5-R, LOT: 100034| PN:1-10013-459,TIBIAL INS SIZE 4-RI 9MM,LOT:100092