BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 3

    MDR report key: 19641830 · Received July 1, 2024

    Report

    Report Number
    3005180920-2024-00489
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 1, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815768
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14-JUN-2024: LOT 2118422: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2022. EXPIRATION DATE: 2027-03-01. 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. ADDITIONAL IMPLANTS INVOLVED; BATCH REVIEW PERFORMED ON 14-JUN-2024: GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 (K090988) LOT 2116013: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2022. EXPIRATION DATE: 2027-02-20. 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. GMK-SPHERE 02.12.0025R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R (K140826) LOT 2117640: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2022. EXPIRATION DATE: 2027-02-06. 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. GMK-SPHERE 02.12.0514FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R (K121416) LOT 2108927: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-SEP-2021. EXPIRATION DATE: 2026-09-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215130 GMK-SPHERE PATELLA RESURFACING SIZE 3 KNEE PATELLA JWH MEDACTA INTERNATIONAL SA 2118422 07630030815768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention