BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS PROX BDY - SM 48MM

    MDR report key: 3329454 · Received September 6, 2013

    Report

    Report Number
    0001825034-2013-03641
    Event Type
    Injury
    Date Received
    September 6, 2013
    Date of Event
    August 26, 2013
    Report Date
    October 23, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWT
    PMA / PMN Number
    PK111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY POSSIBLE PRODUCT IDENTIFICATION. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED. PART/LOT INFORMATION COULD BE: CATEGORY NUMBER - 211215, LOT NUMBER - UNKNOWN, EXPIRATION DATE - UNKNOWN, MANUFACTURE DATE ¿ UNKNOWN; CATEGORY NUMBER - 211216, LOT NUMBER - UNKNOWN, EXPIRATION DATE - UNKNOWN, MANUFACTURE DATE ¿ UNKNOWN; CATEGORY NUMBER - 211217, LOT NUMBER - UNKNOWN, EXPIRATION DATE - UNKNOWN, MANUFACTURE DATE ¿ UNKNOWN.

    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. MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A COMPRESS SHOULDER ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO THE SEGMENT BEING TOO HIGH. THE SEGMENT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442760 COMPR SRS PROX BDY - SM 48MM PROSTHESIS, SHOULDER KWT BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R