BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17161348 · Received June 20, 2023

    Report

    Report Number
    3005180920-2023-00443
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 20, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826184
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 MAY 2023: LOT 173798: 30 ITEMS MANUFACTURED AND RELEASED ON 15-SEP-2017. EXPIRATION DATE: 2022-08-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 22 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY FOR KNEE INSTABILITY AT ABOUT 4 YEARS AND 7 MONTHS POST-PRIMARY. LINER WAS REVISED SUCCESSFULLY WITH A THICKER ONE (FROM 12MM TO 17MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527993 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0212FR 173798 07630030826184

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention