BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L

    MDR report key: 16611982 · Received March 24, 2023

    Report

    Report Number
    3005180920-2023-00179
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 24, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825835
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 3 MARCH 2023. LOT 163324: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2016. EXPIRATION DATE: 2021-MAY-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEM INVOVLED IN THE COMPLAINT, BATCH REVIEW PERFORMED ON 3 MARCH 2023. GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT. 163006 LOT 163006: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-AUG-2016. EXPIRATION DATE: 2021-JUL-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON OBSERVED IN A CT SCAN THAT ALL THE COMPONENTS MAY BE LOOSE. ABOUT 6 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY (SPHERE SYSTEM IMPLANTED; LINER REVISED FROM 12MM TO 14MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583281 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0004L 163324 07630030825835

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention