BEUDAMED
    FDA Adverse Event Summary report: N

    RSP SHOULDER

    MDR report key: 2991301 · Received March 6, 2013

    Report

    Report Number
    1644408-2013-00122
    Date Received
    March 6, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY ON (B)(6) 2013 WAS DUE TO A DISLOCATION AND INFECTION. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2012. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. THE DEVICE HISTORY RECORDS FOR THE REPORTED COMPONENTS WERE EXAMINED. A REVIEW OF THE STERILIZATION RECORDS SHOWS THAT THE DEVICES HAD RECEIVED AN ADEQUATE 25-40 KGY GAMMA RADIATION STERILIZATION DOSE. ALL PRODUCTS IMPLANTED WERE WITHIN THEIR RESPECTIVE EXPIRATION DATES AT THE TIME OF THE ORIGINAL SURGERY. A REVIEW OF THE IMPLANT DEVICE HISTORY RECORDS, PRODUCT COMPLAINT REPORT DATABASE, AND STERILIZATION RECORDS SHOW THAT THE REPORTED COMPONENTS USED IN THE ORIGINAL SURGERY MET STERILIZATION, DESIGN, AND MANUFACTURING REQUIREMENTS. NO OTHER INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO INFECTION THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL. THE DATA REVIEWED IN THIS REPORT SUPPORTS THAT THE INFECTION WAS NOT THE RESULT OF A PRODUCT OR MANUFACTURING PROCESS DEFECT.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT DISLOCATED. THE SURGEON PLANNED ON CHANGING OUT THE BALL AND INSERT BUT FOUND THE PATIENT WAS INFECTED; HE SWITCHED OUT THE POLY INSERT AND RESCHEDULED THE SURGERY FOR A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96334 RSP SHOULDER STANDARD HUMERAL SOCKET INSERT KWS ENCORE MEDICAL, L.P. 856C1012

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention