BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0024L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L

    MDR report key: 13365853 · Received January 27, 2022

    Report

    Report Number
    3005180920-2022-00046
    Event Type
    Injury
    Date Received
    January 27, 2022
    Date of Event
    December 30, 2021
    Report Date
    January 27, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862397
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 JANUARY 2022: LOT 1811313: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2019. EXPIRATION DATE: 2024-02-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW PERFORMED ON 04 JANUARY 2022: GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED # 4 L (K090988) LOT 2000558: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAR-2020. EXPIRATION DATE: 2025-03-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX #4/10 MM L (K121416) LOT 2108898: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-SEPT-2021. EXPIRATION DATE: 2026-08-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING # 2 (K090988) LOT 2108178: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-SEPT-2021. EXPIRATION DATE: 2026-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND PAIN DUE TO A TORN PATELLA TENDON. THE PATHOGEN IS UNKNOWN AND THE REASON FOR THE TORN PATELLA TENDON IS UNKNOWN. AT 23 DAYS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED A ROD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84386 GMK-SPHERE 02.12.0024L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0024L 1811313 07630030862397

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention