BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2885345 · Received December 19, 2012

    Report

    Report Number
    1644408-2012-00665
    Event Type
    Other
    Date Received
    December 19, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    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 WAS IDENTIFIED AS A DISLOCATION AFTER TWO MONTHS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. 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 REPORTS ASSOCIATED WITH THIS PRODUCT AND WAS DISPOSITIONED AS REWORK FOR SCUFFS. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 70TH COMPLAINT FOR THIS PART NUMBER: 40 DUE TO DISLOCATION, TEN DUE TO STABILITY/POOR JOINT ISSUES, SEVEN DUE TO INFECTION, FIVE FOR TRAUMA, THREE FOR DISSOCIATION, TWO DUE TO PAIN, ONE FOR A LABELING ISSUE, ONE ASSEMBLY ISSUE, AND ONE FOR 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 - AN ATTEMPT TO REDUCE UNDER ANESTHESIA WAS ACHIEVED, HOWEVER, THE IMPLANT DISLOCATED EASILY ONCE AGAIN. THE PATIENT WAS REVISED TO A LARGER GLENOSPHERE, A SEMICONSTRAINED LINER, AND A THICKER SHELL.

    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. 862C1172

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention (B)(4), LOT 848C1219| (B)(4), LOT 855C1114