BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2844962 · Received November 14, 2012

    Report

    Report Number
    1644408-2012-00608
    Event Type
    Other
    Date Received
    November 14, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER 3.3 WEEKS OF PATIENT USE. 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 (B)(4) SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED ONE NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS PRODUCT, THE PARTS WERE DISPOSITIONED FOR REWORK DUE TO SURFACE FINISH ISSUES. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE FIRST COMPLAINT FOR THIS PART 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; 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 DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER SEMICONSTRAINED HUMERAL SOCKET INSERT KWS ENCORE MEDICAL, L.P. 861C1009

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention