BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL ANCHOR STEM SIZE 5-6

    MDR report key: 17012009 · Received May 26, 2023

    Report

    Report Number
    1020279-2023-01153
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    October 19, 2021
    Report Date
    May 30, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NJD
    UDI-DI
    00885556873106
    PMA / PMN Number
    K190439
    Removal / Correction Number
    RES 92286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: ENGAGE PARTIAL KNEE SYSTEM INSTRUCTIONS FOR USE SPECIFIES THE FOLLOWING CONTRAINDICATIONS: UNICOMPARTMENTAL REPLACEMENT IS CONTRAINDICATED IN PATIENTS WHO HAVE PERMANENT VALGUS OR VARUS DEFORMITY THAT REQUIRES CORRECTION FOR THE KNEE TO FUNCTION SATISFACTORILY POST-OP. PREREQUISITES FOR PARTIAL KNEE REPLACEMENT INCLUDE: UNICOMPARTMENTAL DISEASE WITH A CORRECTABLE DEFORMITY WITH MINIMAL TO NO LIGAMENT RELEASES NOTE: TIBIA VARA IS NOT CONSIDERED A ¿CORRECTABLE DEFORMITY,¿ THUS THIS PATIENT IS CONTRAINDICATED. 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

    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 A PARTIAL KNEE REPLACEMENT SURGERY PERFORMED ON (B)(6) 2021. THE PATIENT REPORTED WEIGHT BEARING PAIN AT THE JOINT LINE 6 MONTHS POST-OP. SURGEON RECOMMENDED PATIENT TO WAIT AS PRIOR EXPERIENCE AND LITERATURE SUGGESTS THAT PAIN WOULD RESOLVE AS IMPLANTS SETTLED IN OVER TIME. PATIENT WAS REPORTEDLY NOT WILLING TO WAIT AND OPTED FOR A REVISION TO A TKA. SURGEON NOTED THAT HER LONG LIMB ALIGNMENT POST-SURGERY WAS ¿NOT THAT GREAT¿. PATIENT WAS SUCCESSFULLY CONVERTED TO A CEMENTED PRIMARY TKA ON (B)(6) 2021 WITH NO AUGMENTS AND MINIMAL BONE LOSS DUE TO THE REVISION PROCEDURE. ALSO, SURGEON NOTED THAT PATIENT MAY NOT HAVE BEEN A GOOD CANDIDATE FOR CEMENTLESS UKA AS SHE HAD A TIBIA VARA DEFORMITY IN HER LEFT TIBIA THEY MAY HAVE CONTRIBUTED TO HER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728627 TIBIAL ANCHOR STEM SIZE 5-6 PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, NJD SMITH & NEPHEW, INC. 100074 00885556873106

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other PN: 1-10003-400 / LOT: 100011| PN: 1-10012-550 / LOT: 100061| PN: 1-10013-560 / LOT: 100100