BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R

    MDR report key: 18386908 · Received December 22, 2023

    Report

    Report Number
    3005180920-2023-01027
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    November 30, 2023
    Report Date
    February 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826542
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 04 JANUARY 2024:5 YEARS AFTER PRIMARY CEMENTED TKA, INSTABILITY DEVELOPS AND PROBABLY ALSO (UNREPORTED) ANTERIOR KNEE PAIN. THE SURGEON PROCEEDS THEN TO SECONDARY RESURFACING OF PATELLA AND TO AUGMENT THE JOINT STABILITY WITH A THICKER INSERT. BOTH CAUSES (SECONDARY ANTERIOR KNEE PAIN AND SECONDARY LIGAMENT LAXITY) ARE NORMAL DISEASE PROGRESSION AND THE REOPERATION WAS THEREFORE NOT CAUSED BY A FAILURE OF THE FORMER TREATMENT.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-DEC-2023: LOT 1810394: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAR-2019. EXPIRATION DATE: 2024-03-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 YEARS AND 10 MONTHS AFTER PRIMARY, THE PATIENT WAS REVISED BECAUSE OF INSTABILITY. THE LINER WAS CHANGED WITH A THICKER ONE (10MM TO 14MM) AND PATELLAR BONE HAS BEEN RESURFACED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291195 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 1810394 07630030826542

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention