BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 12909141 · Received December 1, 2021

    Report

    Report Number
    3005180920-2021-00934
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    November 3, 2021
    Report Date
    December 1, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01 DECEMBER 2021: LOT 1902679: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JUL-2019. EXPIRATION DATE: 2024-07-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED. BATCH REVIEWS PERFORMED ON 01 DECEMBER 2021: GMK-SPHERE 02.12.0310FL TIBIAL INSERT FIXED SPHERE FLEX #3/10 MM L (K121416) LOT 1900365: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2019. EXPIRATION DATE: 2024-04-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT 1900601: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2019. EXPIRATION DATE: 2024-04-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0023R FEMORAL COMPONENT SPHERE CEMENTED # 3+ R (K140826) LOT 1901887: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2019. EXPIRATION DATE: 2026-06-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY 2 YEARS AND 1 MONTH AFTER PRIMARY DUE TO SUSPECTED INFECTION. ALL DEVICES REVISED SUCCESSFULLY AND MEDACTA SEMI CONSTRAINED PROTHESIS IMPLANTED. FINALLY THE INFECTION WAS NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807539 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1203L 1902679 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention