BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 L

    MDR report key: 14839824 · Received June 28, 2022

    Report

    Report Number
    3005180920-2022-00493
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    May 31, 2022
    Report Date
    June 28, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825897
    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 (B)(6) 2022. LOT 152871: 48 ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 45 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L (K090988) LOT 142707: 14 ITEMS MANUFACTURED AND RELEASED ON 29-JUL-2014. EXPIRATION DATE: 2019-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0610FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM L (K121416) LOT 147263: 25 ITEMS MANUFACTURED AND RELEASED ON 22-APR-2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) LOT 151413: 110 ITEMS MANUFACTURED AND RELEASED ON 10-AUG-2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 6 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043094 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 L TOTAL KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0007L 152871 07630030825897

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention