BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 7MM STD

    MDR report key: 3863620 · Received June 10, 2014

    Report

    Report Number
    0001825034-2014-05400
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 15, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. ADDED PATIENT AGE UPDATED EVENT DESCRIPTION WITH NEW INFORMATION FROM OPERATIVE NOTES.

    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. FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION PERTAINING TO EVENT DETAILS AND PRODUCT IDENTIFICATION ARE IN PROCESS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, BIOMET WILL FORWARD A SUPPLEMENTAL REPORT TO THE FDA. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PRODUCT IDENTIFICATION AND EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO INFECTION AND A PERIPROSTHETIC FRACTURE DISTAL TO THE HUMERAL STEM. THE HUMERAL COMPONENTS AND GLENOSPHERE WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO SUSPECTED INFECTION. THE HUMERAL STEM WAS REPLACED WITH A CEMENT SPACER AND THE HUMERUS WAS PLATED. THE PATIENT WAS TREATED WITH SIX WEEKS OF ANTIBIOTICS. A SECOND STAGE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO NON-UNION OF THE HUMERUS. AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED, BONE GRAFT WAS PLACED AND ALL COMPONENTS, INCLUDING THE CEMENT SPACER, WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVERSE SHOULDER PROCEDURE APPROXIMATELY TWO (2) YEARS AGO. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO INFECTION AND PERIPROSTHETIC FRACTURE DISTAL TO THE HUMERAL STEM. THE HUMERAL COMPONENTS AND GLENOSPHERE WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338510 COMP PRIMARY STEM 7MM STD PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 853830

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R