BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10852272 · Received November 17, 2020

    Report

    Report Number
    3005180920-2020-00806
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    October 18, 2020
    Report Date
    November 17, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826344
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 OCTOBER 2020: LOT 1810390: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAR-2019. EXPIRATION DATE: 28-FEB-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION DELAYED INFECTION IN CEMENTED TKA, 16 MONTHS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING TKA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. OTHER DEVICES INVOLVED GMK-SPHERE 02.12.0023R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R LOT. 1811324 (K140826) BATCH REVIEW PERFORMED ON 30 OCTOBER 2020: LOT 1811324: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2019. EXPIRATION DATE: 10-MAR--2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.T4I3R TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R LOT. 187199 (K121416) BATCH REVIEW PERFORMED ON 30 OCTOBER 2020: LOT 187199: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JAN-2019. EXPIRATION DATE: 20-DEC--2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 1 YEAR AND 4 MONTHS FROM THE PRIMARY SURGERY DUE TO AN INFECTION ((B)(6)). THE SURGEON REVISED AL IMPLANTS AND PERFORMED A WASHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318126 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/10 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0310FR 1810390 07630030826344

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention