BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT SIZE 5-LEFT MED 9MM

    MDR report key: 17011713 · Received May 26, 2023

    Report

    Report Number
    1020279-2023-01151
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    September 21, 2021
    Report Date
    June 26, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NJD
    UDI-DI
    00885556873670
    PMA / PMN Number
    K190439
    Removal / Correction Number
    RES 92286 AND Z-1673-202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H3, H6: X-RAYS SHOW WELL-ALIGNED IMPLANTS THAT ARE WELL-APPROXIMATED TO THE BONE. IT WAS REPORTED THAT THERE WAS NO SIGN OF INFECTION OR DISRUPTION. 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. E1: INITIAL REPORTER NAME AND ADDRESS.

    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, 6 MONTHS AFTER UNICOMPARTMENTAL KNEE ARTHROPLASTY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY FROM CEMENTLESS UKA TO CEMENTED UKA ON 21-SEP-2021. DURING THIS SURGERY, THE ANCHOR REMOVAL TOOL TIP BROKE. THE IMPLANTS WERE REMOVED WITHOUT ISSUE AND THERE WAS NO REPORTED DAMAGE TO THE IMPLANTS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437070 TIBIAL INSERT SIZE 5-LEFT MED 9MM PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, NJD SMITH & NEPHEW, INC. 100130 00885556873670

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| R 1-10003-510 / LOT# 100018| 1-10011-300 / LOT# 100071| 1-10012-500 / LOT# 100045| 1-50100-230 / LOT# 200037| 1-50100-455 / LOT# 200038| 1-50100-455 / LOT# 200225