BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R

    MDR report key: 11899533 · Received May 28, 2021

    Report

    Report Number
    3005180920-2021-00436
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 28, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826382
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25.MAY.2021: LOT 2009019: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-NOV-2020. EXPIRATION DATE: 2025-10-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0023R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R (K140826) LOT. 2010184. BATCH REVIEW PERFORMED ON 25.MAY.2021: LOT 2010184: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JAN-2021. EXPIRATION DATE: 2026-01-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: FEW HOURS AFTER PRIMARY CEMENTED TKA WITH A MEDIALLY STABILIZED DEVICE, THE PATIENT DISLOCATES ANTERIORLY. THE DEVICES ARE THEN EXCHANGED TO A SEMICONSTRAINED VERSION. THE CAUSE OF THIS EVENT IS MOST PROBABLY DUE TO INSUFFICIENT LIGAMENT STABILITY OF THE KNEE; THERE IS NO REASON TO SUSPECT A DEVICE MALFUNCTION, NOR WAS IT REPORTED.

    Description of Event or Problem · 1

    AFTER THE PRIMARY KNEE SURGERY (THE SAME DAY), IN POST-OP RECOVERY, IT WAS OBSERVED THAT THE PATIENT DISLOCATED ANTERIORLY FROM THE TIBIA (FEMUR FROM INSERT). THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796225 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R KNEE FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0312FR 2009019 07630030826382

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention