BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYN POR PLUS HA SO STEM SZ 11

    MDR report key: 4222380 · Received November 4, 2014

    Report

    Report Number
    1020279-2014-00674
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 17, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LPH
    PMA / PMN Number
    K002996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. OUR INVESTIGATION INCLUDED A REVIEW OF COMPLAINT HISTORY WHICH REVEALED NO PRIOR COMPLAINTS FOR THE LISTED LOTS/FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 13GM15558B AND 14CM05139 REVEALED DISCREPANCIES DURING THE MANUFACTURING PROCESS; HOWEVER THESE DISCREPANCIES WERE IDENTIFIED AS NOT RELATED TO THE REPORTED INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REMAINING LOT DID NOT REVEAL ANY MANUFACTURING OR MATERIAL ABNORMALITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF THE STERILIZATION RECORDS SHOW THE PRODUCT WAS STERILIZED ACCORDING TO STERILIZATION RELEASE DOCUMENTATION FROM QUALITY CONTROL. WITHOUT THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    REVISION SURGERY WAS REPORTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707999 SYN POR PLUS HA SO STEM SZ 11 PROSTHETIC HIP JOINT LPH SMITH & NEPHEW, INC. 13GM15558B

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 71322047, 71302800