BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENGAGE POROUS TIBIAL TRAY SZ 5-LT MED

    MDR report key: 19967115 · Received August 12, 2024

    Report

    Report Number
    1020279-2024-01572
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    September 15, 2022
    Report Date
    September 29, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NJD
    UDI-DI
    00885556873199
    PMA / PMN Number
    K190439
    Removal / Correction Number
    Z-1672-2023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. DEVICE BATCH NUMBER WAS NOT PROVIDED, THUS, AN EVALUATION OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. A REVIEW OF COMPLAINT HISTORY FOR THE PREVIOUS 24 MONTHS DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR ENGAGE PARTIAL KNEE SYSTEM REVEALED THAT EARLY OR LATE LOOSENING HAS BEEN IDENTIFIED IN ADVERSE EFFECTS AND COMPLICATIONS. THERE IS NOT ENOUGH DATA AVAILABLE TO CONCLUDE THAT THE OVERALL CLINICAL BENEFIT OUTWEIGHS THE POTENTIAL RISK PROFILE WHEN COMPARED TO THE STATE OF THE ART. THE EXISTING DATA IDENTIFIES A POTENTIAL SIGNAL THAT THE PERFORMANCE IS AN OUTLIER VS THE STATE OF THE ART WITH RESPECT TO THE RISK FOR REVISION. IN ADDITION, A HISTORICAL REVIEW CONCLUDED THAT NO PREVIOUS ESCALATED ACTIONS FOR THIS TYPE OF ISSUE WERE IDENTIFIED. HOWEVER, AS A 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 EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE ABNORMAL MOTION OVER TIME, BONE DEGENERATION, SIZE SELECTED, LACK OF INGROWTH, OSTEOLYSIS AND/OR TRAUMATIC INJURY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE NUMBER: (B)(4). H10: SMITH & NEPHEW IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 C.F.R. PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A LEFT PKA SURGERY WITH THE ENGAGE CEMENTLESS PARTIAL KNEE SYSTEM, THE PATIENT EXPERIENCED A TIBIA LOOSENING. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IN UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2486168 ENGAGE POROUS TIBIAL TRAY SZ 5-LT MED PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, NJD SMITH & NEPHEW, INC. UNKNOWN 00885556873199

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention 1-10013-109/TIBIAL INSERT SIZE 1-LEFT MED 9MM