BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L

    MDR report key: 11782829 · Received May 6, 2021

    Report

    Report Number
    3005180920-2021-00355
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 6, 2021
    Report Date
    May 6, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862397
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 APRIL 2021 LOT 2000506: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-APR-2020. EXPIRATION DATE: 2025-04-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEM INVOLVED IN THE EVENT: GMK-SPHERE 02.12.0517FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/17 MM L (K121416) LOT. 171058. BATCH REVIEW PERFORMED ON 15 APRIL 2021: LOT 171058: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUL-2017. EXPIRATION DATE: 2022-06-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE PATIENT HAD BECOME LOOSE LATERALLY (FEMUR WAS MOBILIZED) AND WAS UNSTABLE. THE CAUSE OF THE LOOSENESS AND INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT, AND ADDED A FLUTED EXTENSION STEM AS WELL AS A FEMORAL WEDGE 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683848 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0024L 2000506 07630030862397

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention