BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRAL IMPACT DISTAL CENTRALIZER

    MDR report key: 6395722 · Received March 10, 2017

    Report

    Report Number
    0001825034-2017-01480
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    February 16, 2017
    Report Date
    June 8, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWL
    PMA / PMN Number
    PK984028
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - PART: 12-162609 NAME: COCR INTEGRAL CENTRALIZER LOT: 204490. PART: 12-1139012 NAME: ENDO II MOD HEAD LOT: 730590. PART: 139247 NAME: ENDO II TAPER LOT: 607230.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS DEVICE WAS DETERMINED TO NOT BE REPORTABLE AS IT WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S HIP ARTHROPLASTY WAS REVISED DUE TO PAIN. THE HEAD, LINER AND CUP WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177565 INTEGRAL IMPACT DISTAL CENTRALIZER PROSTHESIS, HIP KWL BIOMET ORTHOPEDICS N/A 528330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R