BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER BIAS STEM

    MDR report key: 6173366 · Received December 14, 2016

    Report

    Report Number
    0001822565-2016-04632
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    November 30, 2016
    Report Date
    December 14, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE AS THERE IS NO ALLEGED DEFICIENCY WITH THE PRODUCT EXPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED SURGEON STATED THAT THE PATIENTS HIP ARTHROPLASTY WAS REVISED DUE TO POLYETHYLENE WEAR AND THERE ARE NO ALLEGED DEFICIENCY WITH THE PRODUCTS THAT WERE EXPLANTED AS THEY WERE IN SITU FOR 30+ YEARS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT THAT HAD A HIP ARTHROPLASTY IS BEING CONSIDERED FOR A REVISION FOR UNKNOWN REASONS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824781 UNKNOWN ZIMMER BIAS STEM HIP PROSTHESIS KWZ ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other