BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S3 SHOULDER PLATE 3 HOLE RIGHT

    MDR report key: 3430194 · Received October 25, 2013

    Report

    Report Number
    0001825034-2013-04921
    Event Type
    Injury
    Date Received
    October 25, 2013
    Date of Event
    September 25, 2013
    Report Date
    January 31, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXT
    PMA / PMN Number
    PK060290
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. (NOTE: BIOMET, INC. ACQUIRED THE TRAUMA PRODUCT LINE FROM DEPUY ORTHOPAEDICS, INC. (¿DEPUY¿) ON JUNE 16, 2012 (¿CLOSING DATE¿). PURSUANT TO THE WRITTEN AGREEMENT BETWEEN BIOMET AND DEPUY, BIOMET AGREED TO BE RESPONSIBLE FOR REGULATORY REPORTING FOR EVENTS WHICH OCCURRED AFTER THE CLOSING DATE REGARDLESS OF THE ENTITY THAT ACTUALLY MANUFACTURED THE PRODUCT OR ACTUALLY SOLD THE PRODUCT TO THE HEALTHCARE PROVIDER. BECAUSE THE PRODUCT THAT IS THE SUBJECT MATTER WAS MANUFACTURED BEFORE THE CLOSING DATE, PLEASE BE ADVISED THAT THE SUBJECT PRODUCT WAS MANUFACTURED BY DEPUY AND NOT BIOMET.) DEPUY ALSO SOLD THE PRODUCT THAT IS THE SUBJECT MATTER TO THE HEALTHCARE PROVIDER INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION RIGHT PROXIMAL HUMERUS PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE PEGS WOULD NOT LOCK INTO THE PLATE. AS A RESULT, AN HOUR DELAY OCCURRED AND COMPETITOR PRODUCTS WERE UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548887 S3 SHOULDER PLATE 3 HOLE RIGHT APPLIANCE, FIXATION LXT BIOMET ORTHOPEDICS N/A RM055A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R