BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BÜRCH-SCHNEIDER ACETABULAR COMPONENT

    MDR report key: 6137684 · Received December 1, 2016

    Report

    Report Number
    0001822565-2016-04405
    Event Type
    Injury
    Date Received
    December 1, 2016
    Report Date
    November 29, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    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 0009613350-2017-00094.

    Description of Event or Problem · 1

    IT IS REPORTED THAT TWO PATIENTS UNDERWENT HIP ARTHROPLASTY REVISIONS USING THE BÜRCH-SCHNEIDER ANTI-PROTRUSIO CAGE. SUBSEQUENTLY, THE PATIENTS EXPERIENCED RESPIRATORY DISTRESS FIVE TO EIGHTEEN YEARS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788705 UNKNOWN BÜRCH-SCHNEIDER ACETABULAR COMPONENT HIP PROSTHESIS KWZ ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other