BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN BIOMET KNEE PROSTHESIS

    MDR report key: 6255808 · Received January 17, 2017

    Report

    Report Number
    0001822565-2017-00180
    Event Type
    Death
    Date Received
    January 17, 2017
    Report Date
    February 24, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. NO DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. THIS DEVICE IS USED FOR TREATMENT. UNABLE TO PERFORM A COMPATIBILITY CHECK BASED ON THE PROVIDED INFORMATION. UNABLE TO PERFORM A COMPLAINT HISTORY REVIEW BASED ON THE PROVIDED INFORMATION. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION TO THE CAUSE OF THE EVENT. THIS ARTICLE WAS WRITTEN BY GAVIN P. HART, MD, JEFFREY S. KNEISL, MD, BRYAN D. SPRINGER, MD, JOSHUA C PATT, MD, MADHAV A. KARUNAKAR, MD.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED VIA JOURNAL ARTICLE, A PATIENT DIED PRIOR TO LEAVING THE HOSPITAL DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40293 UNKNOWN BIOMET KNEE PROSTHESIS PROSTHESIS, KNEE JWH ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death