BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GLENOID

    MDR report key: 3870634 · Received June 12, 2014

    Report

    Report Number
    0001825034-2014-05507
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    August 13, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. A REVISION HAS BEEN INDICATED DUE TO PATIENT ANATOMY AND IS NOT RELATED TO A PRODUCT ISSUE.

    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. INITIAL REPORTER - UNKNOWN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE IMPLANT DATE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. IMPLANT DATE - APPROXIMATELY 17 YEARS AGO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER ARTHROPLASTY APPROXIMATELY SEVENTEEN YEARS AGO. SUBSEQUENTLY, A REVISION PROCEDURE HAD BEEN INDICATED DUE TO A LOOSENED GLENOID; HOWEVER, THE REVISION PROCEDURE HAS NOT BEEN SCHEDULED DUE TO HEALTH OF THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO A LOOSENED GLENOID; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348554 UNKNOWN GLENOID PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention