BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIOUS HIP PROSTHESES SYSTEMS

    MDR report key: 2040290 · Received April 5, 2011

    Report

    Report Number
    1825034-2011-00228
    Event Type
    Injury
    Date Received
    April 5, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL INFORMATION RECEIVED WAS LIMITED TO PRESENTATION CONTENT. NO PART NUMBERS/LOT NUMBERS WERE OR HAVE BEEN RECEIVED. SURGEON WAS CONTACTED IN AN ATTEMPT TO DETERMINE WHETHER THESE EVENTS WERE PREVIOUSLY REPORTED TO BIOMET AND/OR FDA. ADDITIONAL INFORMATION RELATED TO THE NATURE OF THE EVENTS HAS BEEN PROVIDED TO BIOMET. WE ARE ABLE TO CONFIRM THAT AT LEAST FIVE OF THE EVENTS HAVE BEEN REPORTED BY BIOMET PREVIOUSLY; HOWEVER, IT IS NOT KNOWN AT THIS POINT WHETHER ALL EVENTS WERE REPORTED TO BIOMET WHICH WOULD ALLOW US TO REPORT AS APPLICABLE. ONGOING REVIEW OF INFORMATION IS BEING PERFORMED AND IF FURTHER DETAILS OR EVENTS INCLUDED IN THIS PRESENTATION ARE IDENTIFIED, ADDITIONAL MDRS WILL BE FILED. (B)(4). COMMON DEVICE NAME - PRODUCT CODE KWA IS FOR THE METAL ON METAL HIP SYSTEMS. FOR THE UNSPECIFIED METAL/POLY HIP SYSTEMS, COMMON DEVICE NAME IS PROSTHESIS, HIP, PRODUCT CODE: LPH OR KWZ. THE FOLLOWING WARNINGS ARE IN THE PACKAGE INSERT AND STATE THAT THESE TYPES OF EVENTS CAN OCCUR: LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY. MATERIAL SENSITIVITY REACTIONS. DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS. EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION. WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES. THIS REPORT FILED APRIL 5, 2011.

    Additional Manufacturer Narrative · 1

    IN REVIEW, THE JOURNAL ARTICLE IS RELAYING INFORMATION THAT WAS PREVIOUSLY REPORTED IN MDR NUMBERS 1825034-2011-00228 & 1825034-2011-00402/433. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED VERY PRELIMINARY INFORMATION REGARDING SEVERAL REVISIONS WHICH WERE OUTLINED IN A PRESENTATION CONDUCTED BY A SURGEON AT THE AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS CONVENTION. ACCORDING TO THE DETAILS PROVIDED IN THE PRESENTATION, A NUMBER OF REVISIONS FOR SEPARATE HIP SYSTEMS (M2A TAPER, M2A 38MM, M2A MAGNUM, AND UNSPECIFIED METAL/POLY HIP SYSTEMS) OCCURRED FOR THE FOLLOWING REASONS: (32) PATIENTS WERE REVISED DUE TO ASCEPTIC LOOSENING. (17) PATIENTS WERE REVISED DUE TO METALLOSIS/HYPERSENSITIVITY. (5) PATIENT REVISED DUE TO DISLOCATION. (5) PATIENTS REVISED FOR UNKNOWN REASONS, BUT ACETABULAR CUPS WERE FOUND TO BE WELL-FIXED. (16) PATIENTS WERE REVISED DUE TO INFECTION. (3) PATIENTS DUE TO ACETABULAR LOOSENING. (1) PATIENT DUE TO ACETABULAR FRACTURE. (2) PATIENTS DUE TO WEAR/LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIOUS HIP PROSTHESES SYSTEMS PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R