BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO II HEAD

    MDR report key: 6395715 · Received March 10, 2017

    Report

    Report Number
    0001825034-2017-01479
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    February 16, 2017
    Report Date
    May 23, 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: 162656 NAME: INGL ANDR IMPCT DSTL PSTNR 9 LOT: 528330. PART: 139247 NAME: ENDO II TAPER INSERT LOT: 607230.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S HIP ARTHROPLASTY WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178000 ENDO II HEAD PROSTHESIS, HIP KWL BIOMET ORTHOPEDICS N/A 730590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R