BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT SIZE 5-LEFT MED 9MM

    MDR report key: 17011329 · Received May 26, 2023

    Report

    Report Number
    1020279-2023-01146
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    June 17, 2021
    Report Date
    June 1, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NJD
    UDI-DI
    00885556873670
    PMA / PMN Number
    K190439
    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

    H3, H6: RESULT OF INVESTIGATION: IN THIS CASE, THERE WAS NO EVIDENCE OF SERIOUS PATIENT INJURY, AND THE SURGEON MAY HAVE BEEN UNAWARE OF THE EXISTING CLINICAL GUIDANCE MEDIAL PAIN RELATED TO BONE REMODELING FOR CEMENTLESS UKA. 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 PARTIAL RIGHT KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED UNEXPLAINED PAIN AROUND 5-MONTHS POST-OPERATION. X-RAY AND CT IMAGING SHOWED NO EVIDENCE OF PATIENT INJURY OR DEVICE MALFUNCTION. IMPLANTS WERE INTACT, WELL PLACED, AND THE SURROUNDING BONE HAD NO EVIDENCE OF DAMAGE. CT SHOWED GOOD BONE APPROXIMATION OF THE IMPLANTS. EVEN THOUGH, DUE TO THE PAIN, REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718974 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 78 YR Male Hospitalization| R PRS FMRL CMP SZ6-LFT MDL(PN:1-10003-610,LN:100031)| PRS TBL TRY SZ5-LFT MDL(PN:1-10012-500,LN:100045)| TBL ANCHR STM SZ5-6(PN:1-10011-300,LN:100071)