BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA MODULAR CERAMIC HEAD 28MM HEAD DIAMETER TYPE 16/18 TAPER

    MDR report key: 5901625 · Received August 24, 2016

    Report

    Report Number
    0001825034-2016-03225
    Event Type
    Injury
    Date Received
    August 24, 2016
    Date of Event
    April 3, 2015
    Report Date
    July 25, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS. " THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2015-04804, 2016-03202 & 03225 & 03230). PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCT - BIOMET CERAMIC TAPER ADAPTER CATALOG#: 650-1067 LOT#: 080270; BIOMET FEMORAL STEM CATALOG#: 192410 LOT#: 347410.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY TWO MONTHS POST-IMPLANTATION DUE TO DISLOCATION AND DISASSOCIATION OF THE POLY BEARING FROM THE HEAD. THE CERAMIC HEAD AND HIP BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553773 BIOLOX DELTA MODULAR CERAMIC HEAD 28MM HEAD DIAMETER TYPE 16/18 TAPER PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 241940

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R