BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOW VERSYS STEM

    MDR report key: 5072028 · Received September 11, 2015

    Report

    Report Number
    1822565-2015-01796
    Event Type
    Injury
    Date Received
    September 11, 2015
    Report Date
    August 18, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR REVIEW, THEREFORE ITS CONDITION CANNOT BE DESCRIBED. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE ITEM/LOT NUMBERS ARE UNKNOWN. THE DEVICE WAS USED IN TREATMENT. NO APPLICABLE PATIENT HISTORY IS AVAILABLE FOR REVIEW. COMPATIBILITY OF THE DEVICES IS UNKNOWN. A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED WITH THE LACK OF IDENTIFYING PRODUCT INFORMATION. WITH THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE STATED.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. PLEASE REFERENCE LITERATURE AT THE FOLLOWING LOCATION: WWW.JOSONLINE.ORG/INDEX.PHP/JOS/ARTICLE/DOWNLOAD/2713/1096 (B)(4). OTHER DEVICE USED: CATALOG #UNK, UNKNOWN PALACOS BONE CEMENT, LOT #UNK- THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH (B)(4) PRODUCTS. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT WAS REVISED DUE TO FEMORAL STEM SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601774 UNKNOW VERSYS STEM HIP PROSTHESIS KWZ ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention