BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6036157 · Received October 18, 2016

    Report

    Report Number
    3002806535-2016-00789
    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. (B)(6). (B)(4). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051411. THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04135 AND 3002806535-2016-00789/00791).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED DISLOCATION AND SUBLUXATION OF THE RIGHT HIP NINE DAYS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689247 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