BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TIBIAL INSERT SIZE 4 / 12MM RIGHT

    MDR report key: 4586324 · Received March 4, 2015

    Report

    Report Number
    3005180920-2015-00022
    Event Type
    Injury
    Date Received
    March 4, 2015
    Report Date
    July 28, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03/04/2015: CODE 02.12.0412FR - LOT 140356: (B)(4) ITEMS PRODUCED AND RELEASED ON 03/13/2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM: WASHING AND STERILIZATION CYCLES HAVE BEEN CORRECTLY PERFORMED, FOLLOWING THE SPECIFICATIONS VALID AT THE TIME OF THE PRODUCTION. TO DATE, 10 INSERTS OF THE LOT HAVE BEEN SOLD WITHOUT ANY OTHER SIMILAR ISSUE. ON 02/11/2015, THE AGENT: CONFIRMED THE INFECTION (THE PATHOGEN WAS STAPHYLOCOCCUS AUREUS). WROTE THAT: "I WAS NOT ABLE TO OBTAIN THE EXPLANTED MATERIAL BECAUSE IT WAS THROWN AWAY AND NOT REQUESTED BY THE DOCTOR."

    Additional Manufacturer Narrative · 1

    ON JULY 17, 2015, IT WAS PREPARED A FINAL REPORT WITH THE INFO COLLECTED DURING THE INVESTIGATION, ALREADY REPORTED IN THE INITIAL REPORT. ON JULY 20, 2015, THE REPORT WAS SENT TO THE INITIAL REPORTED AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149664 GMK SPHERE TIBIAL INSERT SIZE 4 / 12MM RIGHT UHMWPE TIBIAL INSERT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1