BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2844927 · Received November 14, 2012

    Report

    Report Number
    1644408-2012-00601
    Event Type
    Other
    Date Received
    November 14, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER TWO WEEKS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. 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. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED ONE NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS PRODUCT DUE TO A REVISION LEVEL CERT ISSUE. THE PARTS WERE ACCEPTABLE PER THE RELATED LE ECO. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 67TH COMPLAINT FOR THIS PART NUMBER: 37 DUE TO DISLOCATION, TEN FOR STABILITY/POOR JOINT, SEVEN DUE TO INFECTION, FIVE TRAUMAS, THREE FOR DISSOCIATION, TWO DUE TO PAIN, ONE FOR A LABELING ISSUE, ONE ASSEMBLY ISSUE, AND ONE DUE TO A FIT ISSUE. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE DISLOCATION WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. SEVERAL FACTORS NOT RELATED TO THE IMPLANT CAN PLAY A ROLE IN DISLOCATION SUCH AS; LOOSE JOINT FROM INADEQUATE SOFT TISSUE AND PATIENT ACTIVITY. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT SUFFERED A DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID HEAD W/RETAINING SCREW/NEUTRAL KWS ENCORE MEDICAL, L.P. 862C1175

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 508-00-032, LOT 855C1145