BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM COCR BIOMET FEM HD STD NK

    MDR report key: 5439395 · Received February 16, 2016

    Report

    Report Number
    3002806535-2016-00068
    Event Type
    Injury
    Date Received
    February 16, 2016
    Date of Event
    April 30, 2015
    Report Date
    January 20, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS PRODUCT IS MANUFACTURED BY ZIMMER (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K042037. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2016-00068 & 0001825034-2016-00513).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY AND UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2015 DUE TO INFECTION. THE FEMORAL HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96690 32MM COCR BIOMET FEM HD STD NK PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 3462851

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R