BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN CEMENTLESS PARTIAL KNEE IMPL

    MDR report key: 17027080 · Received May 30, 2023

    Report

    Report Number
    1020279-2023-01207
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    January 1, 1901
    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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: A REVISION SURGERY WAS CONDUCTED ON AN UNKNOWN DATE. REP WAS ALERTED OF REVISION SURGERY AFTER IT WAS ALREADY CONDUCTED. WAS NOT IN ATTENDANCE AND THUS NO INFORMATION COULD BE GATHERED AT THAT TIME. NO REP WAS AT THE CASE. THEREFORE NO FURTHER INVESTIGATION COULD BE CONDUCTED. 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

    RESULTS OF INVESTIGATION: A REVISION SURGERY WAS CONDUCTED ON AN UNKNOWN DATE. REP WAS ALERTED OF REVISION SURGERY AFTER IT WAS ALREADY CONDUCTED. WAS NOT IN ATTENDANCE AND THUS NO INFORMATION COULD BE GATHERED AT THAT TIME. NO REP WAS AT THE CASE. THEREFORE NO FURTHER INVESTIGATION COULD BE CONDUCTED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER UNICOMPARTMENTAL KNEE ARTHROPLASTY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT, FOR WHICH A REVISION SURGERY WAS CONDUCTED ON AN UNKNOWN DATE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897257 UNKN CEMENTLESS PARTIAL KNEE IMPL PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, NJD SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention