BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPT HIP SYSTEM TAPER STEM INSERTER

    MDR report key: 1915277 · Received November 2, 2010

    Report

    Report Number
    1822565-2010-01069
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Report Date
    May 6, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THIS TYPE OF THREAD DAMAGE MIGHT HAVE BEEN CAUSED DUE TO ONE OR COMBINATION OF THE FOLLOWING FACTORS: IF THE DEVICE IS NOT THREADED PROPERLY WITH THE STEM (I.E. CROSS THREADING OR PARTIAL THREAD ENGAGEMENT). OFF AXIS IMPACTION. DAMAGE CAUSED DURING REPEATED CLEANING AND STEAM STERILIZATION. OFF-LABEL USE (E.G. DEVICE IS USED TO EXTRACT THE STEM, HEAVY IMPACTION FORCE, ETC). BALL PLUNGER MIGHT WENT MISSING DURING CLEANING/AUTOCLAVING. HOWEVER, THIS IS NOT AN EXHAUSTIVE LIST. NO DEFINITIVE CAUSE ANALYSIS CAN BE PERFORMED WITH CERTAINTY. EVAL: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MFG AND INSPECTED TO SPECIFICATION. AS RETURNED, THE DISTAL THREADS ARE FRACTURED AND THERE ARE IMPACTION MARKS ON THE KNOB. THE BALL PLUNGER IS ALSO MISSING. THE TENTATIVE FIELD AGE OF THE DEVICE IS APPROXIMATELY 5 YRS 3 MONTHS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DISTAL THREADS OF THE INSERTER HAVE FRACTURED OFF AND THE BALL PLUNGER IS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPT HIP SYSTEM TAPER STEM INSERTER HIP INSTRUMENT LXH ZIMMER, INC. 60249783

    Patients

    Seq Age Sex Outcome Treatment
    1