BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR CEMENTED PS SIZE 2NARROW / LEFT

    MDR report key: 7845330 · Received September 5, 2018

    Report

    Report Number
    3005180920-2018-00658
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    August 6, 2018
    Report Date
    September 5, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820946
    PMA / PMN Number
    K122232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 SEPTEMBER 2018. LOT 143535: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 JULY 2014. EXPIRATION DATE: 2019-06-30 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. OTHERS DEVICES INVOLVED: TIBIAL INSERT PS FIXED SIZE 2/10MM; REFERENCE 02.07.0210PSF; (K090988). LOT 174622: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 AUGUST 2017. EXPIRATION DATE: 2022-07-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT. TIBIAL TRAY FIXED CEMENTED SIZE 2 L; REFERENCE 02.07.1202L; (K090988). LOT 170414: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 MAY 2017. EXPIRATION DATE: 2022-05-16 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. PATELLA RESURFACING SIZE 1; REFERENCE 02.07.0033RP; (K090988). LOT 171999: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JULY 2017. EXPIRATION DATE: 2022-07-02 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

    ABOUT 10 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR KNEE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688207 GMK-PRIMARY FEMUR CEMENTED PS SIZE 2NARROW / LEFT CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 143535 07630030820946

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention