BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 9144941 · Received October 2, 2019

    Report

    Report Number
    3005180920-2019-00825
    Event Type
    Injury
    Date Received
    October 2, 2019
    Date of Event
    September 4, 2019
    Report Date
    October 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 120 SEPTEMBER 2019 LOT 182888: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-AUG-2018. EXPIRATION DATE: 2023-08-21. 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 DIRECTOR FEW MONTHS AFTER PRIMARY CEMENTED TKA THE TIBIAL COMPONENT BECAME LOOSE AND NEEDED REPLACEMENT. FROM THE VERY SHORT RADIOGRAPH RECEIVED , IT SEEMS THAT THE INTERDIGITATION OF CEMENT IN THE TIBIAL BONE DID NOT ACHIEVE STRONG FIXATION. WE CANNOT DETERMINE THE CAUSES OF THIS CONDITION, BUT WE SEE NO REASON TO THINK THAT THE PROSTHETIC IMPLANT WAS DEFECTIVE. ADDITIONAL IMPLANT INVOLVED IN THIS EVENT: GMK-SPHERE 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L (K121416) LOT. 1902476 BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2019 LOT 1902476: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2019. EXPIRATION DATE: 2024-05-06. 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

    ON THE 2ND OF SEPTEMBER 2019 WE WERE INFORMED THAT A REVISION WOULD HAVE TAKEN PLACE ON THE (B)(6) 2019 (6 MONTHS AFTER PRIMARY SURGERY), FOLLOWING FLEXION PROBLEMS. TIBIAL BASE AND INSERT REVISED. THE INSERT REVISED DURING THIS SURGERY WAS IMPLANTED DURING A PREVIOUS REVISION (DONE IN (B)(6) 2019) ABOUT WHICH WE DO NOT HAVE ANY INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942500 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L CEMENTED KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 182888 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention