BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPT HIP SYSTEM TAPER STEM INSERTER

    MDR report key: 1915196 · Received November 2, 2010

    Report

    Report Number
    1822565-2010-01071
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    May 5, 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

    INFORMATION WAS REC'D FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE DISTAL THREADS ARE FRACTURED ON THE RETURNED DEVICE. THE TENTATIVE FIELD AGE OF THIS INSTRUMENT IS APPROX 5 YRS. THIS TYPE OF 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). HOWEVER, THIS IS NOT AN EXHAUSTIVE LIST. NO DEFINITIVE CAUSE ANALYSIS CAN BE PERFORMED WITH CERTAINTY. EVALUATION: 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. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE STEM INSERTER BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPT HIP SYSTEM TAPER STEM INSERTER HIP INSTRUMENT LXH ZIMMER, INC. 60316990

    Patients

    Seq Age Sex Outcome Treatment
    1