BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L

    MDR report key: 15484042 · Received September 26, 2022

    Report

    Report Number
    3005180920-2022-00736
    Event Type
    Injury
    Date Received
    September 26, 2022
    Date of Event
    September 1, 2022
    Report Date
    September 26, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825859
    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 26 SEPTEMBER 2022: LOT 2201135: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-APR-2022. EXPIRATION DATE: 2027-APR-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. ADDITIONAL INVOLVED IMPLANT: BATCH REVIEW PERFORMED ON 26 SEPTEMBER 2022 ON GMK-SPHERE 02.12.E0512FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L E-CROSS (K202022) LOT. 2110589. LOT 2110589: (B)(4) ITEMS MANUFACTURED AND RELEASED ON11-OCT-2021. EXPIRATION DATE: 2026-SEP-17. 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 1 DAY AFTER THE PRIMARY SURGERY, THE PATIENT REPORTED PAIN AND LAXITY. THE PCL (POSTERIOR CRUCIATE LIGAMENT) AND MCL (MEDIAL COLLATERAL LIGAMENT) WERE FOUND TO BE COMPROMISED, THEREFORE THE SURGEON DECIDED TO REVISE THE FEMORAL COMPONENT AND THE LINER TO SWITCH TO A CONSTRAINED PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044962 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0005L 2201135 07630030825859

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention