BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN CEMENTLESS PARTIAL KNEE IMPL

    MDR report key: 17026933 · Received May 30, 2023

    Report

    Report Number
    1020279-2023-01205
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    September 14, 2021
    Report Date
    June 23, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NJD
    Removal / Correction Number
    RES 92286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE LABELING WAS REVIEWED FOR THE ENGAGE PARTIAL KNEE SYSTEM INCLUDING THE INSTRUCTIONS FOR USE. THE IFU DEFINES SPECIFIC CONTRAINDICATIONS FOR PATIENTS WITH NEUROMUSCULAR DISORDERS, WHICH INCLUDES MULTIPLE SCLEROSIS. IT WAS DETERMINED THAT THE PATIENT WAS NOT A GOOD CANDIDATE FOR A UKA PROCEDURE DUE TO THE PATIENT CO-MORBIDITIES. 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

    INTERNAL REFERENCE NUMBER: CASE (B)(4). H10: 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) 2021, THE PATIENT EXPERIENCED A FALL AND AND FRACTURED THEIR MEDIAL TIBIA ON THE IMPLANTED SIDE. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2021, IN WHICH THE IMPLANTS WERE REMOVED WITH NO EVIDENT FAILURES. THE FRACTURE WAS PLATED AND THE SYSTEM WAS REVISED TO TKA. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509071 UNKN CEMENTLESS PARTIAL KNEE IMPL PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, NJD SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other