BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

    MDR report key: 14346313 · Received May 10, 2022

    Report

    Report Number
    3005180920-2022-00351
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 10, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825866
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 APRIL 2022: LOT 1905069: 80 ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2019. EXPIRATION DATE: 2024-SEP-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 73 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 13 APRIL 2022: GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED # 5 R LOT. 1908382 (K090988): LOT 1908382: 77 ITEMS MANUFACTURED AND RELEASED ON11-FEB-2020. EXPIRATION DATE: 2025-FEB-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 75 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.0035RP PATELLA RESURFACING SIZE 3 LOT. 1908306 (K090988): LOT 1908306: 240 ITEMS MANUFACTURED AND RELEASED ON 07-NOV-2019. EXPIRATION DATE: 2024-OCT-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 236 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND SWELLING. THE SURGEON DECIDED TO REVISE THE PATIENT AND DISCOVERED THAT ALL IMPLANTS WERE LOOSE AND DID NOT BOND WITH THE CEMENT. THE CAUSE OF THIS IS UNKNOWN. AT 1 YEAR AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294801 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R KNEE FEMORAL IMPLANT JWH MEDACTA INTERNATIONAL SA 02.12.0005R 1905069 07630030825866

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention