BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA V-40 CERAMIC HEAD 36/+2,5

    MDR report key: 3261549 · Received August 2, 2013

    Report

    Report Number
    0002249697-2013-02507
    Event Type
    Malfunction
    Date Received
    August 2, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K052718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGE INVOLVING A CERAMIC HEAD WAS REPORTED. THE EVENT WAS CONFIRMED. A VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR). NO SCRATCHES WERE OBSERVED ON THE ARTICULATING SURFACE OF THE HEAD. THERE APPEARS TO BE A METAL TRANSFER MARK ON THE ARTICULATING SURFACE OF THE HEAD. THERE ARE METAL TRANSFER MARKS ON THE DISTAL SURFACE OF THE HEAD AND THE MACHINED TAPERED SURFACE OF THE HEAD THAT ARE CONSISTENT WITH ATTEMPTING TO PUT THE HEAD ONTO A STEM. A MATERIAL ANALYSIS REPORT CONCLUDED THAT: THE DARK MARKS ON THE ARTICULATING SURFACE OF THE HEAD ARE CONSISTENT WITH METAL TRANSFER MARKS FROM CONTACT WITH AN INSTRUMENT. THIS METAL TRANSFER MARK MOST LIKELY OCCURRED DURING EITHER ASSEMBLY OR REMOVAL OF THE HEAD. THE DARK MARKS ON THE DISTAL AND MACHINED TAPERED SURFACES OF THE HEAD ARE CONSISTENT WITH METAL TRANSFER MARKS FROM CONTACT WITH A STEM DURING ATTEMPTING TO SEAT THE HEAD ON THE TRUNNION OF THE STEM. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED DURING THIS EXAMINATION. INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICIAN CONSULTANT. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT THE METAL TRANSFER MARKS ON THE ARTICULATING SURFACE ARE DUE TO CONTACT WITH A SURGICAL INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WE OPENED UP A CERAMIC HEAD AND THE DOCTOR NOTICED A SCRATCH ON THE HEAD. A BACKUP WAS IMMEDIATELY AVAILABLE. NO DELAY IN SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WE OPENED UP A CERAMIC HEAD AND THE DOCTOR NOTICED A SCRATCH ON THE HEAD. A BACKUP WAS IMMEDIATELY AVAILABLE. NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363113 DELTA V-40 CERAMIC HEAD 36/+2,5 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 43697101

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other