BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 2

    MDR report key: 19605508 · Received June 25, 2024

    Report

    Report Number
    3005180920-2024-00454
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 25, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815751
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06-JUN-2024 LOT 2248617: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2023. EXPIRATION DATE: 2028-03-08. 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 DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 06-JUN-2024 GMK-SPHERE 02.12.0004L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L (K121416) LOT 2248161: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2023. EXPIRATION DATE: 2028-02-27. 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. GMK-SPHERE 02.12.0412FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L (K121416) LOT 2201064: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2022. EXPIRATION DATE: 2027-03-09. 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.T3I4L TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L (K121416) LOT 2246820: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2023. EXPIRATION DATE: 2028-03-05. 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

    AT ABOUT 1 YEAR AND 3 WEEKS 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
    449074 GMK-SPHERE PATELLA RESURFACING SIZE 2 KNEE PATELLA JWH MEDACTA INTERNATIONAL SA 2248617 07630030815751

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention