BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 2/12 MM R

    MDR report key: 18992995 · Received March 28, 2024

    Report

    Report Number
    3005180920-2024-00153
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    February 28, 2024
    Report Date
    March 28, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261341
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06-MAR-2024 LOT 2112606: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2021. EXPIRATION DATE: 2026-11-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 7 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (12MM) WITH A THICKER ONE (14MM) AND SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723650 GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 2/12 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2112606 07630971261341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention