BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

    MDR report key: 12758722 · Received November 7, 2021

    Report

    Report Number
    3005180920-2021-00860
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    October 8, 2021
    Report Date
    November 5, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825866
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. KNEE REVISION SURGERY PERFORMED 2 YEARS AND 7 MONTHS AFTER CEMENTED TKA IN A (B)(6) YEAR OLD MAN. NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS AND PRESENCE OF COMORBIDITIES IS AVAILABLE. ACCORDING TO THE REPORT, THE PATIENT REPORTED PAIN AND INSTABILITY. THE DEVELOPMENTAL INSTABILITY IS A RATHER COMMONLY DESCRIBED POSSIBLE COMPLICATION FOLLOWING TKA, BECAUSE SOFT TISSUE MAY STRETCH AND PROVIDE INSUFFICIENT STABILITY. RADIOGRAPHIC IMAGES PROVIDED DON'T ALLOW A PROPER CLINICAL EVALUATION AND THE ORIGIN OF PAIN CANNOT BE DETERMINED. NO CONCLUSION CAN BE DRAWN ON THE BASIS OF AVAILABLE INFORMATION. BATCH REVIEW PERFORMED ON 15 OCTOBER 2021 LOT 183490: 84 ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2018. EXPIRATION DATE: 2023-JUL-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 80 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT. 178634 LOT 178634: 120 ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2018. EXPIRATION DATE: 2023-FEB-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 120 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0512FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R (K121416) LOT. 144290 LOT 144290: 49 ITEMS MANUFACTURED AND RELEASED ON 2-OCT-2014. EXPIRATION DATE: 2019-AUG-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 44 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017.

    Description of Event or Problem · 0

    AT 2 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT HAD REVISION SURGERY DUE TO PAIN AND KNEE INSTABILITY. ALL IMPLANTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659834 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0005R 183490 07630030825866

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention