BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA OPTION HIP SYSTEM CERAMIC HEAD

    MDR report key: 5954287 · Received September 15, 2016

    Report

    Report Number
    3002806535-2016-00738
    Event Type
    Injury
    Date Received
    September 15, 2016
    Date of Event
    March 28, 2016
    Report Date
    September 30, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS DEVICE IS NOT MARKETED OR MANUFACTURED BY ZIMMER BIOMET IN THE US; HOWEVER, THIS REPORT IS BEING FILED AS A SIMILAR DEVICE IS MARKETED OR MANUFACTURED BY ZIMMER BIOMET US UNDER 510K NUMBER K051411. 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 AND IMPROPER POSITIONING 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 1 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-01479 AND 3002806535-2016-00738).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. UDI - (B)(4). REVIEW OF MANUFACTURING HISTORY FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DIMENSIONAL ANALYSIS OF THE CERAMIC HEAD WERE NOTED TO BE CONFORMING TO PRINT; THEREFORE, DEVICE LIKELY LEFT THE MANUFACTURER CONFORMING. SCRATCHES WERE NOTED ON THE CERAMIC HEAD, LIKELY CAUSED FROM CONTACT WITH THE METAL CUP WHILE DISLOCATING FROM THE BEARING. A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    PATIENT'S RIGHT HIP WAS REVISED 6 DAYS POST-IMPLANTATION DUE TO DISLOCATION. THE ACETABULAR BEARING WAS REMOVED AND REPLACED WITH A POLYETHYLENE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605103 BIOLOX DELTA OPTION HIP SYSTEM CERAMIC HEAD PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 214630

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R