BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11025983 · Received December 17, 2020

    Report

    Report Number
    3005180920-2020-00906
    Event Type
    Injury
    Date Received
    December 17, 2020
    Date of Event
    November 18, 2020
    Report Date
    December 17, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826382
    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 28 NOVEMBER 2020. LOT#: 163070: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-AUG-2016. EXPIRATION DATE: 2021-07-21. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: INSERT REVISION AND PATELLA RESURFACING IN TKA 3 YEARS AND 10 MONTHS AFTER PRIMARY FOR JOINT INSTABILITY AND PAIN. 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. A SECONDARY PATELLAR RESURFACING SHOULD NOT BE CONSIDERED A FAILURE: SOMETIMES SURGEONS PREFER TO POSTPONE PATELLA ARTHROPLASTY IN ORDER TO PRESERVE MAXIMUM QUANTITY OF BONE AND REDUCE TRAUMA, AND PROCEED TO TREAT ONLY IN CASE OF PERSISTENT ANTERIOR PAIN. THIS IS NOT A PROBLEM DUE TO ANY IMPLANT DEFECT OR MALFUNCTION.

    Description of Event or Problem · 1

    THE PATIENT HAD PAIN AND THE KNEE WASN'T STABLE, THEREFORE, THE SURGEON DECIDED TO CHANGE TO A THICKER INLAY AND PUT A PATELLA (3 YEARS AND 10 MONTHS AFTER PRIMARY SURGERY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493588 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0312FR 163070 07630030826382

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention