BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    MDR report key: 18948317 · Received March 21, 2024

    Report

    Report Number
    3005180920-2024-00188
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    August 3, 2023
    Report Date
    March 21, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 MARCH 2024. LOT 1909420: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2019. EXPIRATION DATE: 2024-08-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED. BATCH REVIEWS PERFORMED ON 15 MARCH 2024: GMK-SPHERE 02.07.2804L TIBIAL TRAY FIXED CEMENTED SIZE 4 L TINBN COATED (K202684) LOT 174139: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-OCT-2017. EXPIRATION DATE: 2022-10-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0705L FEMORAL COMPONENT SPHERE TINBN COATED SIZE 5 L (K202684) LOT 166354: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2017. EXPIRATION DATE: 2021-12-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: IN A TKA PATIENT, OPERATED FOR THE FIRST TIME IN MID 2020, SUSPECTED LOOSENING AND INFECTION IS DETECTED AFTER 1.5 YEARS, THE JOINT IS REOPENED, WASHED, AND THE INSERT REPLACED. HOWEVER, TWO MORE YEARS AFTERWARDS, INSTABILITY AND LOOSENING ARE NOW CONFIRMED AND REVISION OF ALL COMPONENTS IS REQUIRED. NO INFECTION IS DETECTED AT THIS TIME: IT IS HOWEVER POSSIBLE THAT THE INITIAL INFECTION HAS WEAKENED THE CEMENT-BONE INTERFACE AND THIS COULD NEVER BE RECUPERATED. NO OTHER CLEAR EXPLANATION OF THE EVOLUTION COMES TO MIND. NO REASON TO SUSPECT A DEFECTIVE OR MALFUNCTIONING DEVICE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY TOTAL KNEE REPLACEMENT ON (B)(6) 2020. ON (B)(6) 2022 REVISION SURGERY FOR SUSPECTED TIBIAL TRAY LOOSENING DUE TO INFECTION. ONLY THE LINER WAS REVISED. NO FURTHER INFORMATION IS AVAILABLE. ON THE (B)(6) 2023 REVISION SURGERY FOR TIBIAL TRAY, FEMORAL IMPLANTS LOOSENING AND KNEE INSTABILITY. TIBIAL TRAY, TIBIAL STEM, FEMUR AND LINER REVISED SUCCESSFULLY. A 2 MM THICKER LINER HAS BEEN IMPLANTED. PATELLA IMPLANT NOT REVISED. DURING THE REVISION SOME TISSUES WERE TAKEN FOR SEPTIC TESTS. THE TEST RESULTS WERE NEGATIVE; NO INFECTION WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755178 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 1909420 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention