BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 6016452 · Received October 11, 2016

    Report

    Report Number
    0001825034-2016-04062
    Event Type
    Injury
    Date Received
    October 11, 2016
    Report Date
    June 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MEH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE IS (OR MAY BE) NEEDED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS COMPLAINT WAS FOR A REQUEST FOR PRODUCT IDENTIFICATION ONLY. THERE WAS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR PERFORMANCE OF THE PRODUCT. AS SUCH, THIS INFORMATION IS CONSIDERED AN INQUIRY AND THE COMPLAINT FILE IS BEING CLOSED AS NOT A COMPLAINT. IF ADDITIONAL INFORMATION IS RECEIVED THAT ALLEGES A PRODUCT DEFICIENCY, THE COMPLAINT WILL BE RE-OPENED AND EVALUATED AT THAT TIME.

    Description of Event or Problem · 1

    A REVISION PROCEDURE HAS BEEN INDICATED DUE TO AN UNKNOWN REASON; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668849 UNKNOWN HIP PROSTHESIS, HIP MEH BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention