BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

    MDR report key: 16157251 · Received January 13, 2023

    Report

    Report Number
    3005180920-2023-00001
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    December 30, 2022
    Report Date
    January 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862410
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON XX JANUARY 2023: LOT 2108388: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2021. EXPIRATION DATE: 2026-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANT: BATCH REVIEW PERFORMED ON 03 JANUARY 2022 ON GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) LOT. 2202669. LOT 2202669: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2022. EXPIRATION DATE: 2027-05-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    DURING REHAB AT 4 MONTHS FROM PRIMARY, PATELLAR DISLOCATION WAS EXPERIENCED. FEMUR, PATELLA IMPLANT AND INSERT REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464353 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L KNEE FEMORAL CEMENTED COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0025L 2108388 07630030862410

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention