BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOD REV 29MM STD CONE TRIAL COMPONENT LEVEL 9006-2-029

    MDR report key: 2925406 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00128
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DHR INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. CHR INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE INVESTIGATION INDICATES THAT THE HEAD OF THE TRIAL BOLT FRACTURED AS A RESULT OF AN OVERLOAD FORCE BEING APPLIED BY THE USER. THE TRIAL BOLT AND THE STEM THREADS SHOWED DAMAGE CONSISTENT WITH THE COMPONENTS STICKING TOGETHER AS A RESULT OF A THIRD BODY MATERIAL. THERE IS NO INDICATION THAT THE THIRD BODY MATERIAL ORIGINATED FROM THE STEM OR THE TRIAL COMPONENT. THERE IS NO INDICATION TO SUGGEST THE EVENT IS DEVICE RELATED. THE SOURCE OF THE THIRD BODY MATERIAL IS MOST LIKELY PATIENT BONE MATTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO REMOVE THE CONE BODY TRIAL FROM THE REAL STEM. HALF OF THE BOLT HEAD BROKE OFF. THERE WAS NO WAY TO SEPARATE THE TRIAL BODY FROM THE STEM. DOCTOR REMOVED THE WHOLE CONSTRUCT. WE WASTED THE 20 X 155 CONICAL STEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO REMOVE THE CONE BODY TRIAL FROM THE REAL STEM. HALF OF THE BOLT HEAD BROKE OFF. THERE WAS NO WAY TO SEPARATE THE TRIAL BODY FROM THE STEM. DOCTOR REMOVED THE WHOLE CONSTRUCT. WE WASTED THE 20 X 155 CONICAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30361 MOD REV 29MM STD CONE TRIAL COMPONENT LEVEL 9006-2-029 INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH P3UKA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other