BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2885341 · Received December 19, 2012

    Report

    Report Number
    1644408-2012-00663
    Event Type
    Other
    Date Received
    December 19, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER 1.8 YEARS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. 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 NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 55TH COMPLAINT FOR THIS PART NUMBER: 26 DUE TO DISLOCATION, SEVEN DUE TO TRAUMA, FIVE DUE TO INFECTION, FOUR FOR DISSOCIATION, FOUR DUE TO INSTABILITY, FOUR DUE TO PAIN, TWO FOR NON-ASSEMBLY, ONE BROKEN SCREW, AND ONE STABILITY/POOR JOINT 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.

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON REMOVED THE 36 NEUTRAL HEAD DUE TO SHOULDER DISLOCATION. THE SURGEON THEN IMPLANTED A SIZE 40 HEAD TO STABILIZE THE SHOULDER.

    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. 869C1063

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention