BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R

    MDR report key: 13652369 · Received March 2, 2022

    Report

    Report Number
    3005180920-2022-00143
    Event Type
    Injury
    Date Received
    March 2, 2022
    Date of Event
    January 31, 2022
    Report Date
    March 2, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862595
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01-MAR-2022 LOT 1811490: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2019. EXPIRATION DATE: 2024-03-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988) LOT. 1903589. BATCH REVIEW PERFORMED ON 01-MAR-2022. LOT 1903589: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2019. EXPIRATION DATE: 2024-06-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON REVISED THE INSERT WITH A THICKER ONE (17 MM) AND PATELLA 2 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1954818 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0313FR 1811490 07630030862595

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention