BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 2+ R

    MDR report key: 14522259 · Received May 27, 2022

    Report

    Report Number
    3005180920-2022-00402
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    April 28, 2022
    Report Date
    July 22, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040711531
    PMA / PMN Number
    K202684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 2 MAY 2022: LOT 2102488: 240 ITEMS MANUFACTURED AND RELEASED ON 08-APR-2021. EXPIRATION DATE: 2026-03-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 230 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    ON THE 15TH OF JULY WE HAVE RECEIVED THE INFOMATION THAT THE REVISION SURGERY WAS PEROFORMED AND THE EVENT DESCRIPTION HAS BEEN CHANGED AS FOLLOWS: AT ABOUT 8 MONTHS FROM PRIMARY THE SURGEON REVISED THE PATIENT FEMUR AND LINER BECAUSE THE FEMUR WAS IMPLANTED IN PRIMARY WITHOUT ENOUGH EXTERNAL ROTATION. THE FEMUR HAS BEEN ADDED AS PRODUCT INVOLVED. GMK-SPHERE 02.12.0722R FEMORAL COMPONENT SPHERE TINBN COATED SIZE 2+ R LOT. 2013265 BATCH REVIEW PERFORMED ON 19 JULY 2022: LOT 2013265: 05 ITEMS MANUFACTURED AND RELEASED ON 30-MAR-2021. EXPIRATION DATE: 2026-03-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PATELLA INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON PLANS TO REVISE THE PATELLA IN (B)(6) 2022 (PRIMARY WAS ON THE (B)(6) 2021). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. MORE DETAILS TO FOLLOW ONCE REVISION TAKES PLACE.

    Description of Event or Problem · 0

    AT ABOUT 8 MONTHS FROM PRIMARY THE SURGEON REVISED THE PATIENT FEMUR AND LINER BECAUSE THE FEMUR WAS IMPLANTED IN PRIMARY WITHOUT ENOUGH EXTERNAL ROTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2606236 GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 2+ R KNEE CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 02.07.0034RP 2013265 07630040711531

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention