BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX #4/10 MM R

    MDR report key: 11106974 · Received January 4, 2021

    Report

    Report Number
    3005180920-2021-00004
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    December 7, 2020
    Report Date
    January 4, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826542
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: BILATERAL INSERT REVISION IN TKA 14 MONTHS AFTER PRIMARY FOR JOINT INSTABILITY. THE INSERT WAS EXCHANGED TO A THICKER ONE. THE DEVELOPMENTAL INSTABILITY IS A RATHER COMMONLY DESCRIBED POSSIBLE COMPLICATION FOLLOWING TKA, BECAUSE SOFT TISSUE MAY STRETCH AND PROVIDE INSUFFICIENT STABILITY. IT IS THEREFORE COMMON PRACTICE TO RESORT TO A THICKER INSERT AND RECREATE SOFT TISSUE TENSION. THIS IS NOT A PROBLEM DUE TO ANY IMPLANT DEFECT OR MALFUNCTION.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 DECEMBER 2020: LOT 1902500: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAY-2019. EXPIRATION DATE: 2024-04-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 14 DECEMBER 2020: LOT 186023: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2018. EXPIRATION DATE: 2023-11-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY ON BOTH KNEES. THE SURGEON PERFORMED A BILATERAL POLY-SWAP AND REVISED THE RIGHT GMK-SPHERE TIBIAL INSERT - FLEX S4R - 10MM TO A GMK-SPHERE TIBIAL INSERT - FLEX S4R - 14MM AND THE LEFT SPHERE INSERT FLEX LEFT 11MM S4 TO A GMK-SPHERE TIBIAL INSERT - FLEX S4L - 14MM, TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY, 1 YEAR AND 2 MONTHS AFTER PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9450 GMK-SPHERE TIBIAL INSERT FIXED FLEX #4/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0410FR 1902500 07630030826542

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention