BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT

    MDR report key: 4408869 · Received January 12, 2015

    Report

    Report Number
    0001032347-2015-00010
    Event Type
    Injury
    Date Received
    January 12, 2015
    Report Date
    December 19, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    PMA / PMN Number
    PK924935
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. IMPLANT AND EXPLANT DATES ARE UNKNOWN. FILE ONE OF THREE FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A REVISION SURGERY DUE TO INFECTION WAS REPORTED. THE SURGEON HAS REQUESTED AN HTR PEKK IMPLANT TO REPLACE THE HTR PMMA IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26540 HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT HTR-PMI LF FRT SP PAR T KKY BIOMET MICROFIXATION N/A 465580

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R