BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L

    MDR report key: 13042814 · Received December 20, 2021

    Report

    Report Number
    3005180920-2021-01003
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    November 29, 2021
    Report Date
    December 20, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862373
    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 01 DECEMBER 2021. LOT 2008776: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-OCT-2020. EXPIRATION DATE: 2025-OCT-14. 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 COMPONENT INVOLVED: GMK-SPHERE 02.12.0210CRL TIBIAL INSERT FIXED SPHERE CR SIZE 2/10 MM L (K181635) LOT. 2007486 LOT 2007486: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-SEP- 2020. EXPIRATION DATE: 2025-AUG-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

    AT 8 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING INSTABILITY AND HYPEREXTENSION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE SURGEON USED A THICKER LINER TO PROVIDE GREATER VARUS/VALGUS STABILITY AND REVISED THE FEMORAL COMPONENT TO GIVE THE PATIENT A POST TO REDUCE HYPEREXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942354 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0023L 2008776 07630030862373

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention