BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CEMENTLESS PARTIAL KNEE IMPL

    MDR report key: 17026947 · Received May 30, 2023

    Report

    Report Number
    1020279-2023-01206
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    August 23, 2021
    Report Date
    June 26, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NJD
    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

    RESULTS OF INVESTIGATION: OVERSTUFFED POLY. TIBIAL CUT WAS PERFORMED WITH THE MAKO ROBOT, WHICH WAS OFF-LABEL USE. SHOWED JOINT TIGHTNESS AT 7MO WAS 1MM MORE THAN TYPICAL, AND 85% BONE CONTACT, WHICH IS WITHIN THE AVERAGE. ADDED TENSION GAGE AS A STANDARD INSTRUMENT IN THE SET TO PREVENT OVERSTUFFING. ACCORDING LITERATURE, THE MOST COMMON REPORTED ISSUES WITH CEMENTED UKA IS ASEPTIC LOOSENING AND UNEXPLAINED PAIN. 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

    H10: INTERNAL COMPLAINT REFERENCE (B)(4). 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, AFTER UNICOMPARTMENTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED PERSISTENT PAIN. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY TO TKA ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT REVISION TO TKA SURGERY WAS SUCCESSFULLY COMPLETED. CONTRIBUTING FACTORS TO THE REVISION ARE DETERMINED TO BE AN OVERSTUFFING OF THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509917 UNKNOWN CEMENTLESS PARTIAL KNEE IMPL PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, NJD SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| H