BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T3 MD RV HP MCREYNOLDS ADAPTER

    MDR report key: 1894852 · Received November 5, 2010

    Report

    Report Number
    2249697-2010-01475
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 13, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "DURING THE SURGERY, THE SURGEON WENT IN TO REMOVE THE IMPLANTS DUE TO AN INFECTION, HE REMOVED THE RESTORATION CONE CONICAL PROXIMAL BODY PER THE TECHNIQUE AND THEN ATTACHED IMPACTOR ADAPTER TO THE CONICAL DISTAL STEM AND ATTACHED THE SLAP HAMMER TO THE DEVICE. HE PROCEEDED TO BACK SLAP THE IMPLANT AFTER SEVERAL HITS WITH THE SLAP HAMMER THE ADAPTER BROKE. THE SURGEON PROCEEDED TO USE VICE GRIPS WITH SLAP HAMMER TO EXPLANTS THE CONICAL DISTAL STEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T3 MD RV HP MCREYNOLDS ADAPTER INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA TACK40D

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention