BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA MODULAR CERAMIC HEAD 32MM STANDARD NECK TYPE 1 TAPER

    MDR report key: 6038089 · Received October 18, 2016

    Report

    Report Number
    3002806535-2016-00791
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    June 26, 2015
    Report Date
    October 13, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    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. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. DATE OF BIRTH - 1944. (B)(4). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051411. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04135 & 3002806535-2016-00789/00790/00791).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO TWO LUXATIONS. DURING THE PROCEDURE, THE FEMORAL HEAD, ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688453 BIOLOX DELTA MODULAR CERAMIC HEAD 32MM STANDARD NECK TYPE 1 TAPER PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 2015011163

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R