BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L

    MDR report key: 16807150 · Received April 25, 2023

    Report

    Report Number
    3005180920-2023-00285
    Event Type
    Injury
    Date Received
    April 25, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 25, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826818
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03-APR-2023. LOT 1900400: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2019. EXPIRATION DATE: 2024-04-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 03-APR-2023. GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT 2111935: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2021. EXPIRATION DATE: 2026-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO OTHER SIMILAR REPORTED CASES DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: 1 YEAR AFTER PRIMARY CEMENTED TKA THE PATIENT COMPLAINS ABOUT INSTABILITY. THE SURGEON PROCEEDS TO A NEW OPERATION AND REPORTS THAT THE PROBABLE CAUSE IS POSTERIOR PAIN. HE REPLACES THE TIBIAL TRAY ADDING AUGMENTS AND STEM. IT IS CONCEIVABLE THAT A PROBLEM MAY HAVE OCCURRED DURING PRIMARY SURGERY WITH THE CEMENTATION PHASE: IN ONE PICTURE THE MEDIAL CEMENTATION OF THE BASEPLATE LOOKS SUBOPTIMAL. THE SURGEON PROCEEDS WITH A NEW TIBIA RESECTION AND ADDS WEDGES, BUT NO OTHER PROBABLE CAUSE OF FAILURE WAS IDENTIFIED. SUCH AN EARLY FAILURE, PARTICULARLY IN A CMENTED TKA, LEADS TO SUSPECT A TECHNICAL PROBLEM THAT COULD NOT BE DETECTED AT THE TIME OF INDEX SURGERY.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO LEFT KNEE INSTABILITY. NO INFECTION AND NO LOOSENING OF THE IMPLANTS WERE FOUND. THE SURGEON REVISED SUCCESSFULLY THE TIBIAL TRAY (SIZE 5), WITH A TRAY OF THE SAME SIZE, AND THE INSERT (FROM 14MM TO 12MM) AND IMPLANTED TWO TIBIAL WEDGES CEMENTED (10MM) AND AN EXTENSION STEM (11MM/65MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187992 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0514FL 1900400 07630030826818

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention