BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER BURCH-SCHNEIDER CAGE

    MDR report key: 6141177 · Received December 2, 2016

    Report

    Report Number
    0001822565-2016-04438
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    April 2, 2002
    Report Date
    November 30, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER.  THIS EVENT WILL/WAS BE REPORTED ON 0009613350-2017-00076.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA JOURNAL ARTICLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT THE PATIENT HAD CRANIAL MIGRATION AT THE 5 YEAR FOLLOW UP ALONG WITH POOR HIP SCORES. AAOS: I, PAPROSKY: 3A, AND HARRIS HIP SCORES 61,61,60 AT 1,2,5 YEARS RESPECTIVELY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791527 UNKNOWN ZIMMER BURCH-SCHNEIDER CAGE HIP PROSTHESIS KWZ ZIMMER, INC. N/A UNK CAGE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR