BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD 46X18X53

    MDR report key: 5940802 · Received September 9, 2016

    Report

    Report Number
    0001825034-2016-03583
    Event Type
    Injury
    Date Received
    September 9, 2016
    Report Date
    October 14, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    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

    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. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2015-02709 AND 03583 AND 03586). REMAINS IMPLANTED.

    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.CONCOMITANT MEDICAL PRODUCT ¿ BIOMET GLENOID CATALOG #: 113849 LOT #:774320, BIOMET COMPREHENSIVE PRIMARY STEM CATALOG #113630 LOT#442490, BIOMET VERSA DIAL TAPER CATALOG #118001 LOT 667170.

    Description of Event or Problem · 1

    IT WAS REPORTED IN MEDICAL RECORDS RECEIVED THAT PATIENT EXPERIENCED NERVE PALSY, SWELLING WITH LIMITED MOBILITY AND PAIN APPROXIMATELY 8 WEEKS POST-IMPLANTATION THAT WAS REOCCURRING UP TO APPROXIMATELY ONE YEAR POST-IMPLANTATION. DURING THE INITIAL PROCEDURE, IT WAS NOTED THAT BLEEDING WAS NOTICED IMMEDIATELY AFTER REMOVING A SECTION OF THE HUMERAL HEAD, AND AN AXILLARY ARTERY REPAIR OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN MEDICAL RECORDS RECEIVED THAT PATIENT EXPERIENCED NERVE PALSY, SWELLING WITH LIMITED MOBILITY AND PAIN APPROXIMATELY 8 WEEKS POST-IMPLANTATION. DURING THE INITIAL PROCEDURE, IT WAS NOTED THAT BLEEDING WAS NOTICED IMMEDIATELY AFTER REMOVING A SECTION OF THE HUMERAL HEAD, AND AN AXILLARY ARTERY REPAIR OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590549 VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD 46X18X53 PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 897250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention