BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERT 90-SRK-142410 MPCS SIZE 4X10MM L (KNEE)

    MDR report key: 8341144 · Received February 14, 2019

    Report

    Report Number
    1226420-2019-00022
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    January 16, 2019
    Report Date
    February 14, 2019
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    JWH
    PMA / PMN Number
    K150496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4) PATIENT INFORMATION INCOMPLETE AND MISSING PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING A POST-OP VISIT AFTER A TKA, THE PATIENT WAS DIAGNOSED WITH AN INFECTION AT THE IMPLANT SITE. THE PATIENT WENT IN FOR A REVISION, THE POLY TRIAL WAS EXPLANTED AND A NEW ONE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132201 INSERT 90-SRK-142410 MPCS SIZE 4X10MM L (KNEE) PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH MEDTRONIC ADVANCED ENERGY, LLC 90-SRK-142410 XXA19HA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention