BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 3122611 · Received May 15, 2013

    Report

    Report Number
    1644408-2013-00278
    Event Type
    Other
    Date Received
    May 15, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS DUE TO DISLOCATION AFTER 1.4 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 WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS KEPT BY THE HOSPITAL AND NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED ONE NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT: NCMR#18225 REPORTED 23 PARTS, 508-00-001 HAD INCORRECT LASER MARKINGS; ALL PARTS WERE REWORKED TO SPECIFICATION. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 44TH COMPLAINT FOR THIS PART NUMBER: FIVE REVISION SURGERIES, ONE FOR A FAILED DEVICE, 20 DUE TO DISLOCATION, ONE DUE TO PAIN, FIVE DUE TO INFECTION, TWO DUE TO TRAUMA, ONE FOR DEVICE LOOSENING, THREE FOR STABILITY/POOR JOINT ISSUES, ONE DUE TO FIXATION, AND FIVE FOR DISSOCIATION. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE DISLOCATION WAS MOST LIKELY DUE TO THE PATIENT FALLING. THE INFORMATION REVIEWED SHOWED THE PRODUCT MET ALL DESIGN, MATERIAL, AND MANUFACTURING SPECIFICATIONS. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT FELL AND DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214690 RSP SHOULDER HUMERAL SOCKET SHELL, +8MM OFFSET KWS ENCORE MEDICAL, L.P. 854C1055

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention (B)(4), LOT 862C1211| (B)(4), LOT 855C1146