BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2851045 · Received November 19, 2012

    Report

    Report Number
    1644408-2012-00626
    Event Type
    Other
    Date Received
    November 19, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER THREE WEEKS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE HOSPITALIZATION - INITIAL OR PROLONGED AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. 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 66TH COMPLAINT FOR THIS PART NUMBER: 29 DUE TO DISLOCATION, 12 DUE TO INFECTION, FOUR DUE TO PAIN, THREE DUE TO TRAUMA, THREE FOR INSTABILITY, THREE FOR A FRACTURED BONE, THREE FOR A TIGHT JOINT/LIMITED RANGE OF MOTION, TWO FOR DISSOCIATION, ONE DUE TO SUBLUXATION, ONE FOR AN ASSEMBLY PROBLEM, ONE DUE TO A CRACKED DEVICE, ONE FOR A MACHINE DEFECT, ONE IMPINGEMENT, AND ONE REVISION. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE DISLOCATION WAS MOST LIKELY DUE TO THE PATIENT BEING NONCOMPLIANT. 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 PATIENT WAS NON COMPLIANT AND SUFFERED A SHOULDER DISLOCATION.

    Description of Event or Problem · 1

    REVISION SURGERY- THE PT SUFFERED A SHOULDER DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER STANDARD HUMERAL SOCKET INSERT KWS ENCORE MEDICAL, L.P. 855C1135

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention