BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 3971706 · Received July 31, 2014

    Report

    Report Number
    0001825034-2014-06690
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWC
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO INFECTION. DURING THE PROCEDURE, THE SCREWS AND BASEPLATE COULD NOT BE REMOVED. THE SPACER MOLD WAS IMPLANTED AROUND THE BASEPLATE. THERE WAS A DELAY OF 45 MINUTES IN THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO INFECTION. DURING THE PROCEDURE, THE SCREWS AND BASEPLATE COULD NOT BE REMOVED. THE SPACER MOLD WAS IMPLANTED AROUND THE BASEPLATE. THERE WAS A DELAY OF 45 MINUTES IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447309 UNKNOWN SCREW SCREW, FIXATION HWC BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R