BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINECTIV TECHNOLOGY NECK PROVISIONAL

    MDR report key: 1253437 · Received December 5, 2008

    Report

    Report Number
    1822565-2008-00884
    Event Type
    Malfunction
    Date Received
    December 5, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ZIMMER, INC
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS ALLEGED THAT A G2 KINECTIV NECK PROVISIONAL BROKE DURING IMPACTION. UPON INSPECTION, A FRACTURE OF ONE OF THE DISTAL TABS WAS CONFIRMED. MOST LIKELY, THERE WAS SOFT TISSUE OR DEBRIS BETWEEN THE PROVISIONAL AND STEM OR THE PROVISIONAL WAS MISALIGNED AND IMPACTION CAUSED A FRACTURE. HOWEVER, THE SURGICAL TECHNIQUE DOES NOT RECOMMEND IMPACTION OF PROVISIONAL NECKS. THE RECOMMENDED METHOD FOR INSERTING THE NECKS AS PER SURGICAL TECHNIQUE ENCOURAGES INSERTION BY HAND OR USING THE KINECTIV NECK INSERTER. EVALUATION: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. THE SPECIMEN HAS A POTENTIAL FIELD AGE OF APPROXIMATELY 1 YEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NECK PROVISIONAL BROKE OFF UPON IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINECTIV TECHNOLOGY NECK PROVISIONAL HIP INSTRUMENT LXH ZIMMER, INC NA 60822419

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK