BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ACETABULAR CUP

    MDR report key: 6337208 · Received February 16, 2017

    Report

    Report Number
    3002806535-2017-00076
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Report Date
    February 16, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. HJORTH ET AL. "EQUAL PRIMARY FIXATION OF RESURFACING STEM, BUT INFERIOR CUP FIXATION WITH ANTEROLATERAL VERSUS POSTERIOR SURGICAL APPROACH. A 2 YEAR BLINDED RANDOMIZED RADIOSTEREOMETRIC AND DUAL X-RAY ABSORPTIOMETRY STUDY OF METAL-ON-METAL HIP RESURFACING ARTHROPLASTY"

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE INDIVIDUAL MIGRATION PATTERNS OF TT (TOTAL TRANSLATION) REVEALED SEVEN CUPS WITH MIGRATION ABOVE THE PRECISION LIMIT OF TT BETWEEN THREE MONTHS AND TWO YEARS. THE INDIVIDUAL MIGRATION PATTERNS OF TR (TOTAL ROTATION) SHOWED 10 CUPS WITH MIGRATION ABOVE THE PRECISION LIMIT OF TR BETWEEN THREE MONTHS AND TWO YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117659 UNKNOWN ACETABULAR CUP PROSTHESIS, HIP KWA BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1