BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER FEMORAL NAIL

    MDR report key: 3888008 · Received June 3, 2014

    Report

    Report Number
    2648920-2014-00142
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    December 4, 2010
    Report Date
    December 13, 2013
    Manufacturer
    ZIMMER
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS PREVIOUSLY SUBMITTED ON 1822565-2014-00028. OPERATIVE NOTES REGARDING THE SURGICAL PROCEDURES PERFORMED WERE PROVIDED. PART AND LOT NUMBERS WERE PROVIDED. ZIMMER CABLE-READY CERCLAGE CABLES WERE USED WITH A BIOMET VHS VARIABLE ANGLE PLATE. PER THE PACKAGE INSERT (87-6203-719-23), "THE CABLE-READY SYSTEM COMPONENT CANNOT BE USED IN CONJUNCTION WITH ANY OTHER CERCLAGE OR BONE PLATE SYSTEMS. ONLY INSTRUMENTS SPECIFICALLY DESIGNED FOR THIS CABLE SYSTEM SHOULD BE USED DURING IMPLANTATION." ADDITIONALLY, THE CABLE-READY PACKAGE INSERT STATES "THE TYPE OF PT AND THE COMPLIANCE OF THE PT MAY AFFECT THE RESULTS OF FIXATION. THE INCIDENCE OF NONUNION IS INCREASED IN PATIENTS KNOWN TO SMOKE. OTHER POOR CANDIDATES FOR SURGERY INCLUDE OBESE OR MALNOURISHED PATIENTS, OR KNOWN ALCOHOL OR DRUG SUBSTANCE ABUSERS. PATIENTS WITH POOR BONE STOCK MAY ALSO BE POOR SURGICAL CANDIDATES." PATIENT HEALTH AND COMPLIANCE IS UNK. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO A RIGHT FEMORAL SHAFT FRACTURE AND A GREATER TROCHANTER FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325559 ZIMMER FEMORAL NAIL HSB ZIMMER 60049404

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention