BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R

    MDR report key: 10091514 · Received May 27, 2020

    Report

    Report Number
    3005180920-2020-00291
    Event Type
    Injury
    Date Received
    May 27, 2020
    Date of Event
    April 30, 2020
    Report Date
    May 27, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826344
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 MAY 2020: LOT 171885: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAY-2017. EXPIRATION DATE: 2022-05-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: SECONDARY PATELLA RESURFACING PERFORMED 2 YEARS AND 4 MONTHS AFTER PRIMARY TOTAL KNEE ARTHROPLASTY DUE TO PAIN IN A (B)(6) YEAR OLD WOMAN. THIS WAS CAUSED BY INTERVENED ARTHRITIS OF THE PATELLO-FEMORAL JOINT. DURING THIS OPERATION, ALSO THE TIBIAL INSERT HAS BEEN CHANGED TO A THICKER ONE DUE TO KNEE INSTABILITY. 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.

    Description of Event or Problem · 1

    ABOUT 2 YEARS AND 4 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR INSTABILITY AND RESIDUAL PAIN. LINER SWAP TO A THICKER ONE AND PATELLA RESURFACING. THE PATELLA BONE WAS FOUND DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558039 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0310FR 171885 07630030826344

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention