BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0025R SPHERE CEMENTED SIZE 5+ R

    MDR report key: 16655187 · Received March 31, 2023

    Report

    Report Number
    3005180920-2023-00207
    Event Type
    Injury
    Date Received
    March 31, 2023
    Date of Event
    November 17, 2020
    Report Date
    March 31, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862427
    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 8 MARCH 2023. LOT 2001664: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUN-2020. EXPIRATION DATE: 2025-MAY-27. 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. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R (K121416) LOT 2002792: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-APR-2020. EXPIRATION DATE: 2025-APR-02. 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 STIFFNESS. THE SURGEON HAD PLANNED TO JUST PERFORM A POLY SWAP BUT INTRAOPERATIVELY FOUND THE PATIENT HAD A FLEXION CONTRACTURE. THE SURGEON THEN OPTED TO REVISE THE FEMUR AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN WHAT CAUSED THE FLEXION CONTRACTURE AFTER ORIGINAL SURGERY. PATIENT PRESENTED TO CLINIC WITH A STIFF KNEE AND REVISION WAS DETERMINED TO BE THE BEST OUTCOME. REVISION SYSTEM IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059647 GMK-SPHERE 02.12.0025R SPHERE CEMENTED SIZE 5+ R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0025R 2001664 07630030862427

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention