BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL NECK SLEEVE

    MDR report key: 3011625 · Received March 19, 2013

    Report

    Report Number
    1043534-2013-00566
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 14, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-00565, 00567.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Additional Manufacturer Narrative · 1

    AFTER THE INITIAL REPORT IT WAS DETERMINED THAT THERE WAS NO COMPLAINT STATED AGAINST THESE PRODUCTS AND NO SERIOUS INJURY THAT OCCURRED. PLEASE VOID THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION LOCATED; UPDATED INCIDENT DESCRIPTION.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO PAIN.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO PAIN. CUP WAS CUT AND REPLACED WITH A DEPUY CUP. THERE WAS LITTLE INGROWTH ON THE CONSERVE CUP SURFACE. THE BALL HEAD WAS TAKEN OUT AND REPLACED AS WELL. THE NECK (PHA0-1254 # 056345329 WAS LEFT IN AND COLD-WELDED. WE COULD NOT ATTEMPT TO TAKE OUT NECK BECAUSE OF THE BROKEN THREADS. WE WERE INFORMED IT WAS THE LEFT SIDE OF THE HIP THAT WAS GOING TO BE REVISED BUT IN FACT IT WAS THE RIGHT HIP THAT WAS OPERATED ON OR ELSE WE WOULD'VE HAD SPECIAL INSTRUMENTS BROUGHT IN TO HELP EXTRACT THE NECK. PREVIOUS RIGHT HIP REVISION CAPTURED ON COMPLAINT # (B)(4). THE NECK WAS CAPTURED IN THAT COMPLAINT AS WELL. ADDITIONAL INFORMATION LOCATED ON 06.20.18: ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114919 CONSERVE(R) TOTAL NECK SLEEVE HIP COMPONENT, CODE:LZO LZO WRIGHT MEDICAL TECHNOLOGY, INC. 1404214

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention