BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP/MAGNUM ACETABULAR SHELL

    MDR report key: 6332307 · Received February 15, 2017

    Report

    Report Number
    3002806535-2017-00071
    Event Type
    Injury
    Date Received
    February 15, 2017
    Date of Event
    February 28, 2013
    Report Date
    February 10, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, THIS REPORT IS BEING FILED AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510(K) NUMBER K042037. 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.¿ THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2017-00071 / 00072).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 2.6 YEARS POST-IMPLANTATION DUE TO GROIN PAIN, ELEVATED METAL ION LEVELS, AND PSEUDOTUMOR. DURING THE PROCEDURE, METALLOSIS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116023 RECAP/MAGNUM ACETABULAR SHELL PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1533036

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R