BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BURCH SCHNEIDER CUP

    MDR report key: 6139334 · Received December 1, 2016

    Report

    Report Number
    0001822565-2016-04487
    Event Type
    Injury
    Date Received
    December 1, 2016
    Report Date
    December 1, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE - UNK. IMPLANT DATE - UNK. INFORMATION WAS RECEIVED VIA JOURNAL ARTICLE THAT CAN BE LOCATED AT: HTTPS://WWW.RESEARCHGATE.NET/PUBLICATION/11842073_RECONSTRUCTION_OF_SEGMENTAL_DEFECTS_DURING_REVISION_PROCEDURES_OF_THE_ACETABULUM_WITH_THE_BURCH-SCHNEIDER_ANTI-PROTRUSIO_CAGE.

    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 BE REPORTED ON 0009613350-2017-00392.

    Description of Event or Problem · 1

    IT IS REPORTED THAT ONE PATIENT PATIENT THAT SUFFERED FROM GASTROINTESTINAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789825 UNKNOWN BURCH SCHNEIDER CUP HIP PROSTHESIS KWZ ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other